0A4F4F9BD490A749D5437F821CF06DF1
Regulations for Implementation of the Drug Administration Law of the People's Republic of China
https://www.unodc.org/res/cld/document/chn/regulations-for-implementation-of-the-drug-administration-law-of-the-peoples-republic-of-china_html/Regulations_for_Implementation_of_the_Drug_Administration_Law_of_the_Peoples_Republic_of_China_2002.pdf
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator illegal:
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p.(None): it shall turn over the matter to the original verifying and issuing department for handling.
p.(None):
p.(None): Article 54 For a drug whose production, marketing or use is ordered to be suspended upon decision of the drug
p.(None): regulatory department under the State Council or of the drug regulatory department of the people's government of the
p.(None): province, autonomous region and municipality directly under the Central Government, no advertisement for the drug may
p.(None): be published during the period of suspension; where such an advertisement is already published, the publication shall
p.(None): be discontinued immediately.
p.(None):
p.(None): Article 55 Enterprises publishing advertisements, advertising agents and advertisement publishers shall discontinue
p.(None): immediately the publication of any drug advertisement without approval by the drug regulatory department of the
p.(None): people's government of the province, autonomous region and municipality directly under the Central Government, or whose
p.(None): approval number for drug advertisement is forged, or belongs to others, or is expired, or, whose approval number for
p.(None): drug advertisement is canceled because of other illegal advertising activities.
p.(None):
p.(None): Where a drug advertisement is published in violation of law and the circumstances are serious, the drug regulatory
p.(None): department of the people's government of the province, autonomous region and municipality directly under the Central
p.(None): Government may announce the matter to the public.
p.(None):
p.(None): Chapter VIII Inspection of Drugs
p.(None):
p.(None): Article 56 Drug regulatory departments (including drug regulatory institutions legally established by drug regulatory
p.(None): departments of the people's governments of the provinces, autonomous regions and municipalities directly under the
p.(None): Central Government, the same below) shall supervise and inspect the research and development, production, distribution
p.(None): and use of drugs in accordance with law.
p.(None):
p.(None): Article 57 Sampling of a drug shall be conducted by two or more persons who are responsible for drug supervision and
p.(None): inspection in accordance with the provisions of the drug regulatory
p.(None):
p.(None): department under the State Council.
p.(None):
p.(None): The party whose drug is to be sampled shall provide samples of the drug for testing and shall not refuse.
p.(None):
...
p.(None): based on the extent of punishment set forth in the Drug Administration Law and in the Regulations:
p.(None):
p.(None): (1) passing narcotics, psychotropic substances, medicinal toxic drugs and radioactive pharmaceuticals off as other
p.(None): drugs or vice versa;
p.(None):
p.(None): (2) producing or selling counterfeit or substandard drugs of which the main users are pregnant or parturient women,
p.(None): infants and children;
p.(None):
p.(None): (3) producing or selling biological and blood products which are defined as counterfeit or substandard drugs;
p.(None):
p.(None): (4) producing, selling or using counterfeit or substandard drugs, thus inducing harmful results to people;
p.(None):
p.(None): (5) producing, selling or using counterfeit or substandard drugs again after being punished; or
p.(None):
p.(None): (6) refusing or evading supervision and inspection, or forging, destroying or concealing relevant evidentiary
p.(None): materials, or using sealed and seized articles without authorization.
p.(None):
p.(None): Article 80 Branches of drug regulatory departments shall have the authority to, according to the provisions in the Drug
p.(None): Administration Law and in the Regulations, give administrative sanctions such as warning, fine and confiscation of
p.(None): drugs illegally produced or marketed and illegal gains therefrom.
p.(None):
p.(None): Article 81 Where a drug distributor or medical institution dose not violate the relevant provisions in the Drug
p.(None): Administration Law and in the Regulations and has sufficient evidence to prove its unawareness that the drugs being
p.(None): sold or used are counterfeit or substandard drugs, the said drugs and the illegal gains therefrom shall be confiscated;
p.(None): however, it may be exempted from other administrative punishments.
p.(None):
p.(None): Article 82 Articles confiscated according to the provisions in the Drug Administration Law and in the Regulations shall
p.(None): be dealt with under supervision by drug regulatory departments in accordance with regulations.
p.(None):
p.(None): Chapter X Supplementary Provisions Article 83 The terms used in the Regulations are defined as follows:
p.(None): Drug quality attachment and other marks refer to approval documents for drug production, drug testing reports, drug
p.(None): packages, labels and insert sheets.
p.(None):
p.(None): New drugs refer to the drugs which have not been marketed within the territory of the People's Republic of China.
p.(None):
p.(None): Prescription drugs refer to the drugs that may only be purchased, dispensed or used with prescriptions by licensed
p.(None): doctors or licensed assistant doctors.
p.(None):
p.(None): Non-prescription drugs refer to the drugs announced by the drug regulatory department under the State Council which can
p.(None): be purchased or used by consumers upon their own judgment without prescriptions by licensed doctors or licensed
p.(None): assistant doctors.
p.(None):
p.(None): Pharmaceutical preparations of medical institutions refer to pharmaceutical preparations based on fixed prescriptions
p.(None): which have been dispensed upon approval by medical institutions according to their own clinical needs for their own
...
Political / political affiliation
Searching for indicator party:
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p.(None): drug advertisement is canceled because of other illegal advertising activities.
p.(None):
p.(None): Where a drug advertisement is published in violation of law and the circumstances are serious, the drug regulatory
p.(None): department of the people's government of the province, autonomous region and municipality directly under the Central
p.(None): Government may announce the matter to the public.
p.(None):
p.(None): Chapter VIII Inspection of Drugs
p.(None):
p.(None): Article 56 Drug regulatory departments (including drug regulatory institutions legally established by drug regulatory
p.(None): departments of the people's governments of the provinces, autonomous regions and municipalities directly under the
p.(None): Central Government, the same below) shall supervise and inspect the research and development, production, distribution
p.(None): and use of drugs in accordance with law.
p.(None):
p.(None): Article 57 Sampling of a drug shall be conducted by two or more persons who are responsible for drug supervision and
p.(None): inspection in accordance with the provisions of the drug regulatory
p.(None):
p.(None): department under the State Council.
p.(None):
p.(None): The party whose drug is to be sampled shall provide samples of the drug for testing and shall not refuse.
p.(None):
p.(None): Where the party whose drug is to be sampled refuses the sampling and testing of the drug without justifiable reasons,
p.(None): the drug regulatory department under the State Council and the drug regulatory department of the people's government of
p.(None): the province, autonomous region and municipality directly under the Central Government where it is located may announce
p.(None): a stop of marketing and use of the drug, of which the sampling and testing are refused.
p.(None):
p.(None): Article 58 Where a drug is suspected of being impure or adulterated but unable to be tested by the testing method and
p.(None): through the testing items prescribed in the national drug standards, the drug testing institution may conduct tests by
p.(None): adding testing methods and items upon approval by the drug regulatory department under the State Council, the testing
p.(None): results obtained by using the additional testing methods and items may be taken as the basis for certifying the quality
p.(None): of the drugs.
p.(None):
p.(None): Article 59 The drug regulatory department under the State Council and the drug regulatory departments of the people's
p.(None): governments of the provinces, autonomous regions and municipalities directly under the Central Government shall
p.(None): regularly make announcement on drug quality according to the testing results of samples. In the drug quality
p.(None): announcement shall be included the names of sampled drugs, sources of the samples, their manufacturers, batch numbers,
p.(None): drug strength, testing institutions, drug specifications, results of testing, items failing to pass the test, etc. If a
p.(None): drug quality announcement is improperly made, the department making the announcement shall, within five days from the
p.(None): date of recognition of the improper announcement, make a correction within the scope in which the original one is made.
p.(None):
p.(None): Where the party has any objection to the results of testing conducted by the drug testing institution and applies for
p.(None): re-testing, it shall submit a written application and the original testing report attached to the drug testing
p.(None): institution responsible for re-testing. The samples for re-testing shall be taken from the retaining samples kept by
p.(None): the original testing institution.
p.(None):
p.(None): Article 60 Where the drug regulatory department takes administrative enforcement measures to seal or seize drugs that
p.(None): have been proved potentially harmful to human health and the related evidentiary materials, it shall, within seven days
p.(None): from the date it takes such measures, make a decision on whether or not to file a case; where it is necessary to test
p.(None): such drugs, it shall, within 15 days from the date the testing report is issued, make a decision whether or not to file
p.(None): a case; where the conditions for filing a case are not met, the administrative enforcement measures shall be withdrawn;
p.(None): where the marketing and use of such drugs need to be suspended, a decision shall be made by the drug regulatory
p.(None): department under the State Council or the drug regulatory department of the people's government of the province,
p.(None): autonomous region or municipality directly under the Central Government.
p.(None):
p.(None): Article 61 No fees may be charged for selective drug sampling and testing.
p.(None):
p.(None): Where the party has any objection to the results of testing conducted by the drug testing institution and applies for
p.(None): re-testing, it shall pay in advance the fees for drug testing to the drug
p.(None):
p.(None): testing institution responsible for the re-testing according to the regulations of the drug regulatory department under
p.(None): the State Council or of the drug regulatory department of the people's government of the province, autonomous region or
p.(None): municipality directly under the Central Government. If the results of re-testing are inconsistent with the original
p.(None): testing results, the fees for the re-testing shall be paid by the original testing institution.
p.(None):
p.(None): Article 62 Fees may be collected for certificate issuance, drug registration, drug certification, drug testing for
p.(None): approval and mandatory drug testing according to the provisions of the Drug Administration Law and in the Regulations.
p.(None): The specific standards for collecting fees shall be formulated by the finance department under the State Council and
p.(None): the competent department for pricing under the State Council.
p.(None):
p.(None): Chapter IX Legal Liability
p.(None):
...
Health / Drug Usage
Searching for indicator drug:
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p.(None): Regulations for Implementation of the Drug Administration Law of the People's Republic of China
p.(None): (Promulgated by Decree No.360 of the State Council of the People's Republic of China on August 4, 2002, and effective
p.(None): as of September 15, 2002)
p.(None):
p.(None): Chapter 1 General Provisions
p.(None):
p.(None): Article 1 The Regulations are formulated in accordance with the Drug Administration Law of the People's Republic of
p.(None): China (hereinafter referred to as the Drug Administration Law).
p.(None):
p.(None): Article 2 The drug regulatory department under the State Council shall establish a national drug testing institute.
p.(None):
p.(None): The drug regulatory departments of the people's governments of the provinces, autonomous regions and
p.(None): municipalities directly under the Central Government may establish drug testing institutes within their respective
p.(None): administrative areas. Plans for the establishment of local drug testing institutes shall be proposed by the drug
p.(None): regulatory departments of the people's governments of the provinces, autonomous regions and municipalities
p.(None): directly under the Central Government and submitted to the people's governments of the provinces, autonomous
p.(None): regions and municipalities directly under the Central Government for approval.
p.(None):
p.(None): The drug regulatory department under the State Council and the drug regulatory department of the people's government of
p.(None): a province, autonomous region and municipality directly under the Central Government may, when necessary,
p.(None): designate the testing institutes fulfilling the requirements for drug testing to undertake drug testing.
p.(None):
p.(None): Chapter II Control over Drug Manufacturers
p.(None):
p.(None): Article 3 A Drug Manufacturing Certificate shall be acquired for the establishment of a drug manufacturer according to
p.(None): the following procedures:
p.(None):
p.(None): (1) The applicant shall submit an application to the drug regulatory department of the people's government of the
p.(None): province, autonomous region or municipality directly under the Central Government, where the manufacturing
p.(None): site is to be located. The drug regulatory department of the people's government of the province, autonomous
p.(None): region or municipality directly under the Central Government shall, within 30 working days from the date it
p.(None): receives the application, make a review according to the pharmaceutical industry development programs and policies
p.(None): issued by the State and make a decision on approval or disapproval.
p.(None):
p.(None): (2) After completion of establishment of the planned manufacturer, the applicant shall apply to the original approving
p.(None): department for acceptance inspection. The original approving department shall, within 30 working days from the date it
p.(None): receives the application, arrange an acceptance inspection according to the requirements for the establishment of such
p.(None): manufacturers set forth in Article 8 of the Drug Administration Law; a Drug Manufacturing Certificate shall be issued
p.(None): to the applicant if the inspection is passed. The applicant shall, by holding the Drug Manufacturing Certificate,
p.(None): register with the administrative department for industry and commerce in accordance
p.(None):
p.(None): with law.
p.(None):
p.(None): Article 4 Any drug manufacturer that intends to alter the approved items in the Drug Manufacturing Certificate shall,
p.(None): 30 days prior to the alteration of any approved items, apply to the original certificate-issuing authority for
p.(None): registration of alteration; no approved items may be altered without approval. The original certificate-issuing
p.(None): authority shall make a decision within 15 working days from the date it receives the application. The applicant shall,
p.(None): by holding the Drug Manufacturing Certificate with altered items, register the alteration with the administrative
p.(None): department for industry and commerce in accordance with law.
p.(None):
p.(None): Article 5 Drug regulatory departments at or above the provincial level shall organize inspection of drug manufacturers
p.(None): in accordance with the Good Manufacturing Practice for Pharmaceutical Products (GMP) and the measures and schedule for
p.(None): implementing the GMP formulated by the drug regulatory department under the State Council, and issue a certificate to
p.(None): the manufacturer that complies with the GMP. For the manufacturers producing injections and radioactive pharmaceuticals
p.(None): and for those producing biological products specified by the drug regulatory department under the State Council, the
p.(None): inspection of which shall be conducted by the drug regulatory department under the State Council.
p.(None):
p.(None): The format of GMP certificate shall be uniformly provided for by the drug regulatory department under the State
p.(None): Council.
p.(None):
p.(None): Article 6 Any newly-established drug manufacturer or manufacturer with newly-built drug manufacturing workshops or
p.(None): newly-added dosage forms for production shall, within 30 days from the date it obtains the approval documents for
p.(None): manufacturing drug or from the date of its formal production upon approval, apply to the drug regulatory department for
p.(None): GMP certification as required. The drug regulatory department accepting the application shall, within six months from
p.(None): the date it receives the application, organize an inspection as to the compliance with the GMP requirements by the
p.(None): applying manufacturer. A certificate shall be issued to the manufacturer if the inspection is passed.
p.(None):
p.(None): Article 7 The drug regulatory department under the State Council shall set up a database of GMP inspectors. A GMP
p.(None): inspector shall be qualified as required by the drug regulatory department under the State Council. A GMP inspection
p.(None): shall be conducted by a team of inspectors randomly selected from the database of GMP inspectors according to the
p.(None): regulations of the drug regulatory department under the State Council.
p.(None):
p.(None): Article 8 The valid term of a Drug Manufacturing Certificate is five years. To continue its drug production, the
p.(None): Certificate holders shall, six months prior to the expiry date of the Certificate, apply for the renewal of the Drug
p.(None): Manufacturing Certificate according to the regulations of the drug regulatory department under the State Council.
p.(None):
p.(None): Where a drug manufacturer terminates its drug production or is closed down, its Drug Manufacturing Certificate shall be
p.(None): withdrawn by the original certificate-issuing authority.
p.(None):
p.(None): Article 9 Any drug substance used by a drug manufacturer to produce drug products shall have a drug approval number or
p.(None): an import drug license or a pharmaceutical product license issued by the
p.(None):
p.(None): drug regulatory department under the State Council upon examination, with the exception of Chinese crude drugs and the
p.(None): prepared slices of Chinese crude drugs over which no control by approval number is exercised.
p.(None):
p.(None): Article 10 In accordance with the provisions in Article 13 of the Drug Administration Law, any drug manufacturer being
p.(None): entrusted with contract production of the drug shall have a GMP certificate corresponding to the contracted drug.
p.(None):
p.(None): No vaccines, blood products or other drugs specified by the drug regulatory department under the State Council may be
p.(None): contracted for production.
p.(None):
p.(None): Chapter III Control over Drug Distributors
p.(None):
p.(None): Article 11 For the establishment of a drug wholesaler, the applicant shall submit an application to the drug regulatory
p.(None): department of the people's government of the province, autonomous region or municipality directly under the Central
p.(None): Government, where the projected drug wholesaler is to be located. The drug regulatory department of the people's
p.(None): government of the province, autonomous region or municipality directly under the Central Government shall, within 30
p.(None): working days from the date it receives the application, make a decision on approval or disapproval according to the
p.(None): standards for establishment set forth by the drug regulatory department under the State Council.
p.(None): After completion of establishment of the planned wholesaler, the applicant shall apply to the original approving
p.(None): department for acceptance inspection. The original approving department shall, within 30 working days from the date it
p.(None): receives the application, organize an acceptance inspection according to the requirements for establishment of drug
p.(None): distributors set forth in Article 15 of the Drug Administration Law and issue the Drug Supply Certificate to the
p.(None): applicant if the inspection is passed. The applicant shall, with the Certificate, register with the administrative
p.(None): department for industry and commerce in accordance with law.
p.(None):
p.(None): Article 12 For the establishment of a drug retailer, the applicant shall submit an application to the drug regulatory
p.(None): institution of the municipality divided into districts, or to the drug regulatory institution at the county level which
p.(None): is directly set up by the drug regulatory department of the people's government of the province, autonomous region or
p.(None): municipality directly under the Central Government, where the projected retailer is to be located. The drug regulatory
p.(None): institution accepting the application shall, within 30 working days from the date it receives the application, make a
p.(None): decision on approval or disapproval after the review according to the regulations of the drug regulatory department
p.(None): under the State Council, taking into consideration the number of permanent residents, territory, transportation and
p.(None): practical needs in the place. After completion of establishment of the planned retailer, the applicant shall apply to
p.(None): the original approving department for acceptance inspection. The original approving department shall, within 15 working
p.(None): days from the date it receives the application, organize an acceptance inspection according to the requirements for
p.(None): establishment of drug distributors set forth in Article 15 of the Drug Administration Law and issue a Drug Supply
p.(None): Certificate if the inspection is passed. The applicant shall, with the Certificate, register with the administrative
p.(None): department for industry and commerce in accordance with law.
p.(None):
p.(None): Article 13 Drug regulatory departments of the people's government of the provinces, autonomous regions and
p.(None): municipalities directly under the Central Government shall be responsible for the certification of drug distributors. A
p.(None): drug distributor shall, according to the implementing
p.(None):
p.(None): measures and schedule formulated by the drug regulatory department under the State Council, undergo the Good Supply
p.(None): Practice for Pharmaceutical Products (GSP) inspection organized by the local drug regulatory department of the people's
p.(None): government of the province, autonomous region or municipality directly under the Central Government and obtain a GSP
p.(None): certificate. The format of GSP certificate shall be uniformly provided for by the drug regulatory department under the
p.(None): State Council.
p.(None):
p.(None): All newly-established drug wholesalers and retailers shall, within 30 days from the date they obtain the Drug Supply
p.(None): Certificate, apply for the GSP certification to the drug regulatory departments or institutions which have issued them
p.(None): the Drug Supply Certificate. The drug regulatory institutions accepting drug retailers' applications for certification
p.(None): shall, within seven working days from the date they receive the applications, transfer the applications to the drug
p.(None): regulatory departments of the people's governments of the provinces, autonomous regions or municipalities directly
p.(None): under the Central Government that are responsible for organizing inspection of drug distributors. The drug regulatory
p.(None): departments of the people's governments of the provinces, autonomous regions or municipalities directly under the
p.(None): Central Government shall, within three months from the date they receive the applications, organize inspection of the
p.(None): drug wholesalers or retailers as to their compliance with the GSP according to provisions of the drug regulatory
p.(None): department under the State Council and issue GSP certificates to those passing the inspection.
p.(None):
p.(None): Article 14 A database of GSP inspectors shall be set up by each of the drug regulatory department of the people's
p.(None): governments of the provinces, autonomous regions and municipalities directly under the Central Government. A GSP
p.(None): inspector shall be qualified as required by the drug regulatory department under the State Council. A GSP inspection
p.(None): shall be conducted by a team of inspectors randomly selected from the said database according to the provisions of the
p.(None): drug regulatory department under the State Council.
p.(None):
p.(None): Article 15 The State adopts a classification system for prescription drugs and non-prescription drugs. The State
p.(None): subdivides the non-prescription drugs into Class A drugs and Class B drugs according to the level of safety.
p.(None):
p.(None): Any drug retailer distributing prescription drugs or Class A non-prescription drugs shall have licensed pharmacists or
p.(None): other pharmaceutical technicians whose qualifications are legally recognized. Any retailer distributing Class B
p.(None): non-prescription drugs shall have pharmacy staff members who have passed the examination organized by the local drug
p.(None): regulatory institution of the municipality divided into districts or by the local drug regulatory institution at the
p.(None): county level which is directly set up by the drug regulatory department of the people's government of the province,
p.(None): autonomous region or municipality directly under the Central Government.
p.(None):
p.(None): Article 16 Any drug distributor that intends to alter the approved items in the Drug Supply Certificate shall, 30 days
p.(None): prior to the alteration of any approved items, apply to the original certificating-issuing authority for registration
p.(None): of alteration; no approved items may be altered without approval. The original certificate-issuing authority shall make
p.(None): a decision within 15 working days from the date it receives the application. The applicant shall, by holding Drug
p.(None): Supply Certificate with the altered items, register the alteration with the administrative department for industry and
p.(None): commerce in accordance with law.
p.(None):
p.(None): Article 17 The valid term of a Drug Supply Certificate is five years. To continue its drug
p.(None):
p.(None): distribution, the Certificate holder shall, six months prior to the expiry date of the Certificate, apply for the
p.(None): renewal of the Drug Supply Certificate according to the provisions of the drug regulatory department under the State
p.(None): Council.
p.(None):
p.(None): Where a drug distributor terminates its drug distribution or is closed down, its Drug Supply Certificate shall be
p.(None): withdrawn by the original certificate-issuing authority.
p.(None):
p.(None): Article 18 Where there is no drug retailers at town or country fairs in remote areas with poor communications, the
p.(None): local drug retailers may, after obtaining approval from the local drug regulatory departments of the counties (or
p.(None): municipalities) and being registered with the administrative departments for industry and commerce, set up stores at
p.(None): the fairs to sell non-prescription drugs within the approved scope for drug distribution.
p.(None):
p.(None): Article 19 Drug manufactures, drug distributors and medical institutions engaged in on-line drug transaction through
p.(None): the Internet and the drugs so transacted shall be in conformity with the provisions of the Drug Administration Law and
p.(None): in the Regulations. The administrative measures for on-line drug distribution services shall be formulated by the drug
p.(None): regulatory department under the State Council together with the other relevant departments under the State Council.
p.(None):
p.(None): Chapter IV Control over Pharmaceuticals in Medical Institutions
p.(None):
p.(None): Article 20 To establish a pharmaceutical preparation unit in a medical institution, an application shall be submitted
p.(None): to the local administrative department for health of the people's government of the province, autonomous region or
p.(None): municipality directly under the Central Government, and, after being consented upon examination, be reported to the
p.(None): drug regulatory department of the people's government at the same level for review and approval. Approval shall be
p.(None): given to the medical institution if it passes the review by the said drug regulatory department and a Pharmaceutical
p.(None): Preparation Certificate for Medical Institution shall be issued.
p.(None):
p.(None): The administrative department for health and the drug regulatory department of the people's government of the province,
p.(None): autonomous region or municipality directly under the Central Government shall, within 30 working days from the dates
p.(None): they receive the application respectively, make their own decisions whether or not to consent or approve the
p.(None): application accordingly.
p.(None):
p.(None): Article 21 Any medical institution that intends to alter the approved items in the Pharmaceutical Preparation
p.(None): Certificate for Medical Institution shall, 30 days prior to the alteration of any approved items, apply to the original
p.(None): reviewing and approving authorities for registration of alteration according to the provisions in Article 20 of the
p.(None): Regulations; no approved items may be altered without approval. The original reviewing and approving authorities shall
p.(None): make their own decisions within 15 working days from the dates they receive the application respectively.
p.(None):
p.(None): Any medical institution which intends to add new dosage forms or change dispensing sites shall, after passing the
p.(None): acceptance inspection by the local drug regulatory department of the people's government of the province, autonomous
p.(None): region or municipality directly under the Central Government, go through the registration of alteration of the
p.(None): Pharmaceutical Preparation Certificate for Medical Institution according to the provisions in the preceding paragraph.
p.(None):
p.(None): Article 22 The valid term of a Pharmaceutical Preparation Certificate for Medical Institution is five years. To
p.(None): continue dispensing pharmaceutical preparation, the medical institution shall, six months prior to the expiry date of
p.(None): the Certificate, apply for the renewal of the Pharmaceutical Preparation Certificate for Medical Institution according
p.(None): to the provisions of the drug regulatory department under the State Council.
p.(None):
p.(None): Where a medical institution terminates dispensing Pharmaceutical preparations or is closed down, its Pharmaceutical
p.(None): Preparation Certificate for Medical Institution shall be withdrawn by the original certificate-issuing authority.
p.(None):
p.(None): Article 23 To dispense pharmaceutical preparation, the medical institution shall submit the dossier and samples
p.(None): according to the provisions of the drug regulatory department under the State Council, and the pharmaceutical
p.(None): preparation may only be dispensed after being approved by the local drug regulatory department of the people's
p.(None): government of the province, autonomous region or municipality directly under the Central Government and being issued a
p.(None): pharmaceutical preparation approval number.
p.(None):
p.(None): Article 24 No pharmaceutical preparations dispensed by medical institutions may be marketed or marketed in disguised
p.(None): forms, nor may any advertisement of such pharmaceutical preparations be released.
p.(None):
p.(None): When major disasters, epidemic situations or other emergencies occur, or there is urgent need clinically but no supply
p.(None): of the needed drugs in market, the pharmaceutical preparations dispensed by a medical institution may be used by other
p.(None): designated medical institutions within a specified time limit, upon approval by the drug regulatory department under
p.(None): the State Council or by the drug regulatory department of the people's government of a province, autonomous region and
p.(None): municipality directly under the Central Government.
p.(None):
p.(None): Transfer allocation and use of special pharmaceutical preparations regulated by the drug regulatory department under
p.(None): the State Council, and the transfer allocation and use of pharmaceutical preparations dispensed by medical
p.(None): institutions among provinces, autonomous regions, or municipalities directly under the Central Government shall be
p.(None): subject to the approval by the drug regulatory department under the State Council.
p.(None):
p.(None): Article 25 Pharmacy personnel of medical institutions who check and dispense prescriptions shall be the pharmaceutical
p.(None): technicians whose qualifications are legally recognized.
p.(None):
p.(None): Article 26 When purchasing drugs, medical institutions shall keep authentic and complete records. In the purchase
p.(None): record shall be indicated the adopted name of the drug in China, dosage form, strength, batch number, date of expiry,
p.(None): manufacturer, supplier, purchase volume, purchase price, date of purchase and other items specified by the drug
p.(None): regulatory department under the State Council.
p.(None):
p.(None): Article 27 Drugs provided to patients by the medical institutions shall be within the scope of diagnoses and treatments
p.(None): and dispensed according to the prescriptions of licensed doctors or licensed assistant doctors.
p.(None):
p.(None): The scope of drugs purchased and provided to patients by family planning technical service institutions shall be in
p.(None): conformity with the scope of services approved and the drugs shall be dispensed according to the prescriptions of
p.(None): licensed doctors or licensed assistant doctors.
p.(None):
p.(None): The out-patient departments, clinics and other medical institutions, which are set up by individuals, may not purchase
p.(None): or provide drugs other than those commonly used and those for emergency treatment. The range and category of the drugs
p.(None): commonly used and those for emergency treatment shall be determined by the local administrative department for health
p.(None): of the people's government of the province, autonomous region, or municipality directly under the Central Government
p.(None): together with the drug regulatory department at the same level.
p.(None):
p.(None): Chapter V Control over Drugs
p.(None):
p.(None): Article 28 The institutions for non-clinical safety evaluation and study of drugs shall implement the Good Laboratory
p.(None): Practice for Non-Clinical Laboratory Studies (GLP) and the institution for drug clinical trial shall implement the Good
p.(None): Clinical Practice (GCP). The GLP and GCP shall be formulated by the drug regulatory department under the State Council
p.(None): through respective consultation with the administrative department of science and technology under the State Council
p.(None): and the administrative department for health under the State Council.
p.(None):
p.(None): Article 29 Clinical trials, manufacturing and importation of drugs shall be in conformity with the provisions in the
p.(None): Drug Administration Law and in the Regulations, and shall be reviewed and approved by the drug regulatory department
p.(None): under the State Council. The drug regulatory department under the State Council may authorize the drug regulatory
p.(None): departments of the people's governments of the provinces, autonomous regions and municipalities directly under the
p.(None): Central Government to conduct site inspection of research and development conditions of the drugs being applied, to
p.(None): conduct procedural examination of submitted documents, and to test the pilot samples. The specific measures therefor
p.(None): shall be formulated by the drug regulatory department under the State Council.
p.(None):
p.(None): Article 30 Any clinical trial to be conducted for research and development of a new drug shall be subject to the
p.(None): approval by the drug regulatory department under the State Council in accordance with the provisions in Article 29 of
p.(None): the Drug Administration Law.
p.(None):
p.(None): When the application for conducting clinic trials is approved by the drug regulatory department under the State
p.(None): Council, the applicant shall select institutions for clinical trials from the lawfully certified ones to conduct the
p.(None): trials, and report the selected institutions to the drug regulatory department and the administrative department for
p.(None): health under the State Council for the record.
p.(None):
p.(None): Prior to the drug clinical trial, the institution for drug clinical trial shall provide the subjects or their legal
p.(None): guardians with the truthful information on the trial, and a written informed consent shall be obtained.
p.(None):
p.(None): Article 31 For production of a drug admitted by national drug standards, an application shall, in accordance with the
p.(None): provisions of the drug regulatory department under the State Council, be submitted to the drug regulatory department of
p.(None): the people's government of the province, autonomous region or municipality directly under the Central Government or to
p.(None): the drug regulatory
p.(None):
p.(None): department under the State Council, and the relevant technical data and supporting documents shall be provided. The
p.(None): drug regulatory department of the people's government of the province, autonomous region and municipality directly
p.(None): under the Central Government shall, within 30 working days from the date it receives the application, review and make
p.(None): comments, and report the matter to the drug regulatory department under the State Council for review while notifying
p.(None): the applicant of its comments. If all the requirements are fulfilled upon review, a drug approval number shall be
p.(None): issued by the drug regulatory department under the State Council.
p.(None):
p.(None): Article 32 Where a drug is produced according to an interim standard, an application shall be submitted for
p.(None): formalization of the standard three months prior to the expiry date of the interim standard according to the provisions
p.(None): of the drug regulatory department under the State Council; the drug regulatory department under the State Council
p.(None): shall, within 12 months from the expiry date of the interim standard, review and approve the interim standard as formal
p.(None): one if it fulfills the requirements for the formalization set forth by the drug regulatory department under the State
p.(None): Council. Where an applicant does not make such an application or the original interim standard fails to fulfill the
p.(None): requirements for the formalization, the drug regulatory department under the State Council shall withdraw the interim
p.(None): standard and the approval number for drug production issued on the basis of the said interim standard.
p.(None):
p.(None): Article 33 For alteration of any items indicated in the approval documents and their attachments for new drug research
p.(None): and development, production or importation of a drug, a supplementary application shall be submitted to the drug
p.(None): regulatory department under the State Council; if all the requirements are fulfilled upon the review, an approval shall
p.(None): be given by the drug regulatory department under the State Council.
p.(None):
p.(None): Article 34 The drug regulatory department under the State Council may, based on the needs for protection of public
p.(None): health, set an observation period of not more than five years for new drugs produced by drug manufacturers; and no
p.(None): approval shall be given to any other manufacturers to produce or import the said drugs during the observation period.
p.(None):
p.(None): Article 35The State protects undisclosed data of drug study and others which are independently acquired and submitted
p.(None): by drug manufacturers or sellers to obtain production or marketing approval of the drugs in question which contain new
p.(None): chemical entities. No one may make unfair commercial use of the said data.
p.(None):
p.(None): Within six years from the date a drug manufacturer or seller obtains the approval documents for producing or marketing
p.(None): a drug containing new chemical entities, if any other applicant uses the data mentioned in the preceding paragraph to
p.(None): apply for approval for production or marketing of the drug in question without permission of the original applicant who
p.(None): has obtained the approval, no approval may be given to the other applicants by the drug regulatory department except
p.(None): that the data submitted are acquired independently.
p.(None):
p.(None): No drug regulatory department may disclose the data set forth in the first paragraph of this Article except
p.(None):
p.(None): (1) for the need of public interests; or
p.(None):
p.(None): (2) where steps are taken to ensure that the data are protected against unfair commercial use.
p.(None):
p.(None): Article 36 Any drug applied to be imported shall be the one obtained market authorization in the country or region of
p.(None): manufacturing. A drug without such an authorization may be approved of its importation in accordance with the
p.(None): provisions in the Drug Administration Law and in the Regulations, provided that its safety, efficacy and clinical needs
p.(None): have been confirmed by the drug regulatory department under the State Council.
p.(None):
p.(None): For importation of a drug, an application shall be made according to the provisions of the drug regulatory department
p.(None): under the State Council. A drug may only be imported after an Import Drug License is given if it is produced by a
p.(None): foreign manufacturer, or a Pharmaceutical Product License is given if it is produced by a manufacturer in Hong Kong,
p.(None): Macao or Taiwan of China.
p.(None):
p.(None): Article 37 Any medical institution that urgently needs to import a small amount of drugs shall, with a Practicing
p.(None): License of Medical Institution, submit an application to the drug regulatory department under the State Council, and
p.(None): the drug in question may only be imported upon approval. Such imported drugs shall only be used in the designated
p.(None): medical institution for the specified purpose.
p.(None):
p.(None): Article 38 After import drugs arrive at the port, the drug importer shall file a record with the local drug regulatory
p.(None): department in the place where the port is located with the Import Drug License or Pharmaceutical Product License, the
p.(None): original copy of the certificate of origin, duplicate copy of the purchase contract, packing list, bill of freight,
p.(None): shipping invoice, certificate of analysis for the release of drugs by the manufacturer, insert sheet and other
p.(None): documents. The said drug regulatory department shall review the documents submitted and issue a Drug Import Note if
p.(None): they comply with the requirements. The drug importer shall, with the Drug Import Note, complete with the Customs the
p.(None): formalities for customs declaration and clearance.
p.(None):
p.(None): The drug regulatory department in the place where the port is located shall notify the drug testing institution to
p.(None): conduct sampling and testing of the import drugs on each batch basis with the exception of the circumstances set forth
p.(None): in Article 41 of the Drug Administration Law.
p.(None):
p.(None): Article 39 Vaccines, blood products, diagnostic reagents in vitro for blood donor screening and other biological
p.(None): products regulated by the drug regulatory department under the State Council shall be subject to testing or review for
p.(None): approval according to the provisions of the drug regulatory department under the State Council before being marketed or
p.(None): imported; any product that fails in testing or has not been approved shall not be marketed or imported.
p.(None):
p.(None): Article 40 The State encourages the cultivation of Chinese crude drugs. Control through approval number shall be
p.(None): exercised over the Chinese crude drugs that can be cultivated or raised on a large scale and in an intensified way and
p.(None): whose quality can be controlled and fulfills the requirements laid down by the drug regulatory department under the
p.(None): State Council.
p.(None):
p.(None): Article 41 The drug regulatory department under the State Council shall re-evaluate the drugs approved for production
p.(None): and marketing and, on the basis of the re-evaluation results, it may take measures to order the revision of insert
p.(None): sheet or suspension of production, marketing or use of a drug. For drugs with serious adverse reaction or harmful to
p.(None): human health due to other reasons, the
p.(None):
p.(None): approval documents shall be withdrawn.
p.(None):
p.(None): Article 42 The valid term of a drug approval number, Import Drug License and Pharmaceutical Product License issued by
p.(None): the drug regulatory department under the State Council is five years. To continue its drug production or importation,
p.(None): the applicant shall submit a re-registration application six months prior to the expiry date. When making
p.(None): re-registration of a drug, the relevant data shall be submitted according to the provisions of the drug regulatory
p.(None): department under the State Council. If no application for the re-registration of a drug is made upon expiration of the
p.(None): valid term, or the application fails to comply with the provisions on re-registration of the drug regulatory department
p.(None): under the State Council upon review, the drug approval number, Import Drug License or Pharmaceutical Product License
p.(None): shall be withdrawn.
p.(None):
p.(None): Article 43 No contents involving prevention, treatment or diagnosis of human diseases shall be included in the package,
p.(None): label or insert sheet and the related promotional materials for promoting a non-drug product, except as otherwise
p.(None): provided by laws or administrative regulations.
p.(None):
p.(None): Chapter VI Control over the Packaging of Drugs
p.(None):
p.(None): Article 44 Immediate packaging materials and containers used by drug manufacturers shall fulfill the requirements for
p.(None): medicinal use and the standards for ensuring human health and safety, and be subject to registration upon approval by
p.(None): the drug regulatory department under the State Council.
p.(None):
p.(None): The drug regulatory department under the State Council shall be responsible for working out and issuing the measures
p.(None): for control over immediate packaging materials and containers, the product directories and the requirements and
p.(None): standards for medicinal use.
p.(None):
p.(None): Article 45 Packaging materials and containers selected for production of prepared slices of Chinese crude drugs shall
p.(None): accommodate to drug property. No prepared slices of Chinese crude drug may be marketed whose package fails to conform
p.(None): to regulations. A label shall be printed on or attached to the package of prepared slices of Chinese crude drug.
p.(None):
p.(None): On the label of prepared slices of a Chinese crude drug shall be indicated the name of the drug, grade/weight, origin
p.(None): of production, manufacturer, product batch number and production date; if the said drug is controlled by approval
p.(None): number, the drug approval number shall also be indicated.
p.(None):
p.(None): Article 46 The package, label and insert sheet of a drug shall be printed in accordance with the provisions in Article
p.(None): 54 of the Drug Administration Law and those formulated by the drug regulatory department under the State Council.
p.(None):
p.(None): The trade name of a drug shall conform to the provisions of the drug regulatory department under the State Council.
p.(None):
p.(None): Article 47 The immediate packaging materials and containers used by medical institutions for dispensing pharmaceutical
p.(None): preparations, as well as the labels and insert sheets, shall conform to the provisions in Chapter 6 of the Drug
p.(None): Administration Law and the relevant provisions in the Regulations, and be subject to approval by the local drug
p.(None): regulatory departments of the people's
p.(None):
p.(None): governments of the provinces, autonomous regions or municipalities directly under the Central Government.
p.(None):
p.(None): Chapter VII Control over Drug Pricing and Advertising
p.(None):
p.(None): Article 48 For drug pricing, the State exercises a system under which the prices are fixed or guided by the government
p.(None): or regulated by the market.
p.(None):
p.(None): For drugs listed in the directory of drugs for national basic medical insurance and drugs not listed in the directory
p.(None): but monopolistically manufactured and distributed, their prices shall be fixed or guided by the government; the prices
p.(None): of other drugs shall be regulated with the market.
p.(None):
p.(None): Article 49 For drugs the prices of which are fixed or guided by the government according to law, the competent pricing
p.(None): department of the government shall fix and adjust the prices in accordance with the principle set forth in Article 55
p.(None): of the Drug Administration Law; and, in fixing and adjusting the marketing prices, control over the average social
p.(None): ratio of expense as a percentage of sales of drugs, the ratio of income as a percentage of sales, and wholesale and
p.(None): retail margin shall be manifested. The specific pricing measures shall be formulated by the competent department for
p.(None): pricing under the State Council in accordance with the relevant provisions in the Pricing Law of the People's Republic
p.(None): of China (hereinafter referred to as the Pricing Law).
p.(None):
p.(None): Article 50 For a drug whose price shall be fixed or guided by the government and is so established, the competent
p.(None): department for pricing shall publish the said price and specify the date for going into effect in designated
p.(None): publications in accordance with the provisions in Article 24 of the Pricing Law.
p.(None):
p.(None): Article 51 For a drug whose price is fixed or guided by the government, the competent department for pricing shall, in
p.(None): fixing or adjusting the price, organize experts in pharmaceutical, medical, economic and other fields to conduct
p.(None): assessment; and, if necessary, it shall solicit comments from drug manufacturers, drug distributors, medical
p.(None): institutions, citizens and other relevant units and persons.
p.(None):
p.(None): Article 52 The competent pricing department of the government may, in practicing drug price monitoring according to the
p.(None): provisions in Article 28 of the Pricing Law, appoint certain drug manufactures, drug distributors and medical
p.(None): institutions as drug price monitoring units for the purpose of understanding and analyzing the changes and trends of
p.(None): drug prices; the appointed units shall provide cooperation, support and truthful information.
p.(None):
p.(None): Article 53 For publishing a drug advertisement, the relevant materials shall be submitted to the local drug regulatory
p.(None): department of the people's government of the province, autonomous region and municipality directly under the Central
p.(None): Government where the drug manufacturer is located. The drug regulatory department of the people's government of the
p.(None): province, autonomous region and municipality directly under the Central Government shall, within ten working days after
p.(None): it receives the relevant materials, make a decision upon review on whether to issue the approval number for drug
p.(None): advertisement. Where the approval number for drug advertisement is issued upon review, a record shall be filed with the
p.(None): drug regulatory department under the State Council. The specific measures for
p.(None):
p.(None): drug advertisement shall be formulated by the drug regulatory department under the State Council.
p.(None):
p.(None): For publishing an advertisement for an import drug, an application for approval number for drug advertisement shall be
p.(None): submitted to the local drug regulatory department of the people's government of the province, autonomous region and
p.(None): municipality directly under the Central Government where the import agency is located, in accordance with the
p.(None): provisions in the preceding paragraph of this Article.
p.(None):
p.(None): For publishing an advertisement in the province, autonomous region or municipality directly under the Central
p.(None): Government other than where the drug manufacturer or import agency is located, the enterprise publishing advertisement
p.(None): shall file a record in advance with the drug regulatory department of the province, autonomous region or municipality
p.(None): directly under the Central Government where the advertisement is to be published. If the drug regulatory department of
p.(None): the province, autonomous region or municipality directly under the Central Government accepting the file finds that the
p.(None): approved contents of the drug advertisement does not conform to the regulations on the control of drug advertisement,
p.(None): it shall turn over the matter to the original verifying and issuing department for handling.
p.(None):
p.(None): Article 54 For a drug whose production, marketing or use is ordered to be suspended upon decision of the drug
p.(None): regulatory department under the State Council or of the drug regulatory department of the people's government of the
p.(None): province, autonomous region and municipality directly under the Central Government, no advertisement for the drug may
p.(None): be published during the period of suspension; where such an advertisement is already published, the publication shall
p.(None): be discontinued immediately.
p.(None):
p.(None): Article 55 Enterprises publishing advertisements, advertising agents and advertisement publishers shall discontinue
p.(None): immediately the publication of any drug advertisement without approval by the drug regulatory department of the
p.(None): people's government of the province, autonomous region and municipality directly under the Central Government, or whose
p.(None): approval number for drug advertisement is forged, or belongs to others, or is expired, or, whose approval number for
p.(None): drug advertisement is canceled because of other illegal advertising activities.
p.(None):
p.(None): Where a drug advertisement is published in violation of law and the circumstances are serious, the drug regulatory
p.(None): department of the people's government of the province, autonomous region and municipality directly under the Central
p.(None): Government may announce the matter to the public.
p.(None):
p.(None): Chapter VIII Inspection of Drugs
p.(None):
p.(None): Article 56 Drug regulatory departments (including drug regulatory institutions legally established by drug regulatory
p.(None): departments of the people's governments of the provinces, autonomous regions and municipalities directly under the
p.(None): Central Government, the same below) shall supervise and inspect the research and development, production, distribution
p.(None): and use of drugs in accordance with law.
p.(None):
p.(None): Article 57 Sampling of a drug shall be conducted by two or more persons who are responsible for drug supervision and
p.(None): inspection in accordance with the provisions of the drug regulatory
p.(None):
p.(None): department under the State Council.
p.(None):
p.(None): The party whose drug is to be sampled shall provide samples of the drug for testing and shall not refuse.
p.(None):
p.(None): Where the party whose drug is to be sampled refuses the sampling and testing of the drug without justifiable reasons,
p.(None): the drug regulatory department under the State Council and the drug regulatory department of the people's government of
p.(None): the province, autonomous region and municipality directly under the Central Government where it is located may announce
p.(None): a stop of marketing and use of the drug, of which the sampling and testing are refused.
p.(None):
p.(None): Article 58 Where a drug is suspected of being impure or adulterated but unable to be tested by the testing method and
p.(None): through the testing items prescribed in the national drug standards, the drug testing institution may conduct tests by
p.(None): adding testing methods and items upon approval by the drug regulatory department under the State Council, the testing
p.(None): results obtained by using the additional testing methods and items may be taken as the basis for certifying the quality
p.(None): of the drugs.
p.(None):
p.(None): Article 59 The drug regulatory department under the State Council and the drug regulatory departments of the people's
p.(None): governments of the provinces, autonomous regions and municipalities directly under the Central Government shall
p.(None): regularly make announcement on drug quality according to the testing results of samples. In the drug quality
p.(None): announcement shall be included the names of sampled drugs, sources of the samples, their manufacturers, batch numbers,
p.(None): drug strength, testing institutions, drug specifications, results of testing, items failing to pass the test, etc. If a
p.(None): drug quality announcement is improperly made, the department making the announcement shall, within five days from the
p.(None): date of recognition of the improper announcement, make a correction within the scope in which the original one is made.
p.(None):
p.(None): Where the party has any objection to the results of testing conducted by the drug testing institution and applies for
p.(None): re-testing, it shall submit a written application and the original testing report attached to the drug testing
p.(None): institution responsible for re-testing. The samples for re-testing shall be taken from the retaining samples kept by
p.(None): the original testing institution.
p.(None):
p.(None): Article 60 Where the drug regulatory department takes administrative enforcement measures to seal or seize drugs that
p.(None): have been proved potentially harmful to human health and the related evidentiary materials, it shall, within seven days
p.(None): from the date it takes such measures, make a decision on whether or not to file a case; where it is necessary to test
p.(None): such drugs, it shall, within 15 days from the date the testing report is issued, make a decision whether or not to file
p.(None): a case; where the conditions for filing a case are not met, the administrative enforcement measures shall be withdrawn;
p.(None): where the marketing and use of such drugs need to be suspended, a decision shall be made by the drug regulatory
p.(None): department under the State Council or the drug regulatory department of the people's government of the province,
p.(None): autonomous region or municipality directly under the Central Government.
p.(None):
p.(None): Article 61 No fees may be charged for selective drug sampling and testing.
p.(None):
p.(None): Where the party has any objection to the results of testing conducted by the drug testing institution and applies for
p.(None): re-testing, it shall pay in advance the fees for drug testing to the drug
p.(None):
p.(None): testing institution responsible for the re-testing according to the regulations of the drug regulatory department under
p.(None): the State Council or of the drug regulatory department of the people's government of the province, autonomous region or
p.(None): municipality directly under the Central Government. If the results of re-testing are inconsistent with the original
p.(None): testing results, the fees for the re-testing shall be paid by the original testing institution.
p.(None):
p.(None): Article 62 Fees may be collected for certificate issuance, drug registration, drug certification, drug testing for
p.(None): approval and mandatory drug testing according to the provisions of the Drug Administration Law and in the Regulations.
p.(None): The specific standards for collecting fees shall be formulated by the finance department under the State Council and
p.(None): the competent department for pricing under the State Council.
p.(None):
p.(None): Chapter IX Legal Liability
p.(None):
p.(None): Article 63 A drug manufacturer or distributor shall be punished by the drug regulatory department according to the
p.(None): provisions in Article 79 of the Drug Administration Law under any of the following circumstances:
p.(None):
p.(None): (1) where any newly-established drug manufacturer or any manufacturer with a newly-built workshop or with newly-added
p.(None): dosage forms fails in the GMP certification within the time limit prescribed by the drug regulatory department under
p.(None): the State Council but is still engaged in drug production
p.(None):
p.(None): (2) where any newly-established drug distributor fails in GSP certification within the time limit prescribed by the
p.(None): drug regulatory department under the State Council but is still engaged in drug distribution.
p.(None):
p.(None): Article 64 Any contract giver or acceptor, in violation of the provisions in Article 13 of the Drug Administration Law,
p.(None): giving or accepting the contract for drug production without authorization shall be punished in accordance with the
p.(None): provisions in Article 74 of the Drug Administration Law.
p.(None):
p.(None): Article 65 Where, without approval, anyone who sets up a store to sell drugs at the town or country fairs, or sells
p.(None): drugs in a store at the fairs beyond the approved scope of drug distribution, shall be punished according to the
p.(None): provisions in Article 73 of the Drug Administration Law.
p.(None):
p.(None): Article 66 Any medical institution that uses pharmaceutical preparations dispensed by other medical institutions
p.(None): without approval shall be punished according to the provisions in Article 80 of the Drug Administration Law.
p.(None):
p.(None): Article 67 Any out-patient department, clinic or other medical institution, which are set up by individuals, if
p.(None): providing patients with drugs beyond the defined scope or kinds of drugs, shall be punished according to the provisions
p.(None): in Article 73 of the Drug Administration Law.
p.(None):
p.(None): Article 68 Any medical institution that uses counterfeit and substandard drugs shall be punished according to the
p.(None): provisions in Articles 74 and 75 of the Drug Administration Law.
p.(None):
p.(None): Article 69 Any institution, in violation of the provisions in Article 29 of the Drug Administration
p.(None):
p.(None): Law, conducting a drug clinical trial without approval shall be punished according to the provisions in Article 79 of
p.(None): the Drug Administration Law.
p.(None):
p.(None): Article 70 Where an applicant, in applying for conducting a drug clinical trail, submits false data on drug production
p.(None): procedures, quality specifications, or results of pharmacological and toxicological studies, etc., or submit fraud
p.(None): samples, the drug regulatory department under the State Council shall disapprove the application and give a warning to
p.(None): the applicant; where the circumstances are serious, no application for clinical trial of the said drug submitted by the
p.(None): said applicant may be accepted within three years.
p.(None):
p.(None): Article 71 Where anyone producing prepared slices of Chinese crude drugs without national drug standard fails to comply
p.(None): with the processing procedures formulated by the drug regulatory department of the people's government of the province,
p.(None): autonomous region or municipality directly under the Central Government, or any medical institution dispensing
p.(None): pharmaceutical preparations fails to comply with the standards approved by the drug regulatory department of the
p.(None): people's government of the province, autonomous region and municipality directly under the Central Government,
p.(None): punishment shall be imposed thereupon according to the provisions in Article 75 of the Drug Administration Law.
p.(None):
p.(None): Article 72 Where the drug regulatory department and its staff members, in violation of regulations, release undisclosed
p.(None): experimental data or other materials submitted by a manufacturer or seller for obtaining approval of production or
p.(None): marketing of a drug containing new chemical entities, thus resulting in losses to the applicant, the drug regulatory
p.(None): department shall be liable for compensation in accordance with law. After compensating the losses, the drug regulatory
p.(None): department shall order the staff members who disclose the said data in purpose or have serious negligence to partially
p.(None): or fully bear the compensation and shall also impose administrative sanctions on those who are directly liable
p.(None): therefor.
p.(None):
p.(None): Article 73 Any drug manufacturer or distributor producing or distributing drugs or any medical institution dispensing
p.(None): pharmaceutical preparations, whose package, labels or insert sheets are in violation of the provisions in the Drug
p.(None): Administration Law and in the Regulations, shall be punished according to the provisions in Article 86 of the Drug
p.(None): Administration Law.
p.(None):
p.(None): Article 74 Any drug manufacturer, distributor or medical institution altering any items licensed for manufacturing,
p.(None): distributing, or dispensing drugs without completing the formalities for registration of alteration as required shall
p.(None): be given a warning by the original certificate-issuing department and be ordered to complete the said formalities
p.(None): within a time limit. Its Drug Manufacturing Certificate, Drug Distribution Certificate or Pharmaceutical Preparation
p.(None): Certificate for Medical Institution shall be announced as nullified if it fails to do so within the time limit, and
p.(None): punishment shall be given according to the provisions in Article 73 of the Drug Administration Law if it continues its
p.(None): production and distribution activities.
p.(None):
p.(None): Article 75 Anyone violating the provisions in Articles 48, 49, 50, 51 and 52 of the Regulations concerning the control
p.(None): over drug pricing shall be punished according to the relevant provisions in the Pricing Law.
p.(None):
p.(None): Article 76 Where the approved content of a drug advertisement is altered without authorization,
p.(None):
p.(None): the advertiser shall be ordered by the drug regulatory department to discontinue publishing the said advertisement
p.(None): without delay, and punishments shall be given by the original approving drug regulatory department according to the
p.(None): provisions in Article 92 of the Drug Administration Law.
p.(None):
p.(None): After the drug regulatory department withdraws the drug advertisement approval number, it shall notify the organ in
p.(None): charge of advertising supervision and control of the matter within five working days from the date the administrative
p.(None): decision is made. The organ in charge of advertising supervision and control shall, within 15 working days from the
p.(None): date it receives the notification from the drug regulatory department, make an administrative decision for handling the
p.(None): matter according to the relevant provisions in the Advertisement Law of the People's Republic of China.
p.(None):
p.(None): Article 77 Where any enterprise published a drug advertisement outside the province, autonomous region or municipality
p.(None): directly under the Central Government where the drug manufacturer or import drug agent is located without filing a
p.(None): record with the drug regulatory department of the province, autonomous region or municipality directly under the
p.(None): Central Government where the drug advertisement is published, the drug regulatory department of the province,
p.(None): autonomous region or municipality directly under the Central Government shall order the enterprise to make a
p.(None): rectification within a time limit. If the enterprise fails to make any rectification within the time limit, advertising
p.(None): activities carried out in the place for the said drug shall be discontinued.
p.(None):
p.(None): Article 78 Where the drug regulatory department finds that a drug advertisement is published without approval by the
p.(None): drug regulatory department of the people's government of the province, autonomous region or municipality directly under
p.(None): the Central Government, the drug regulatory department of the people's government of the province, autonomous region or
p.(None): municipality directly under the Central Government shall notify the organ in charge of advertising supervision and
p.(None): control to investigate and handle the matter in accordance with law.
p.(None):
p.(None): Article 79 Where anyone that, in violation of the provisions set forth in the Drug Administration Law and in the
p.(None): Regulations, commits any of the following acts shall be given heavier punishments by the drug regulatory department
p.(None): based on the extent of punishment set forth in the Drug Administration Law and in the Regulations:
p.(None):
p.(None): (1) passing narcotics, psychotropic substances, medicinal toxic drugs and radioactive pharmaceuticals off as other
p.(None): drugs or vice versa;
p.(None):
p.(None): (2) producing or selling counterfeit or substandard drugs of which the main users are pregnant or parturient women,
p.(None): infants and children;
p.(None):
p.(None): (3) producing or selling biological and blood products which are defined as counterfeit or substandard drugs;
p.(None):
p.(None): (4) producing, selling or using counterfeit or substandard drugs, thus inducing harmful results to people;
p.(None):
p.(None): (5) producing, selling or using counterfeit or substandard drugs again after being punished; or
p.(None):
p.(None): (6) refusing or evading supervision and inspection, or forging, destroying or concealing relevant evidentiary
p.(None): materials, or using sealed and seized articles without authorization.
p.(None):
p.(None): Article 80 Branches of drug regulatory departments shall have the authority to, according to the provisions in the Drug
p.(None): Administration Law and in the Regulations, give administrative sanctions such as warning, fine and confiscation of
p.(None): drugs illegally produced or marketed and illegal gains therefrom.
p.(None):
p.(None): Article 81 Where a drug distributor or medical institution dose not violate the relevant provisions in the Drug
p.(None): Administration Law and in the Regulations and has sufficient evidence to prove its unawareness that the drugs being
p.(None): sold or used are counterfeit or substandard drugs, the said drugs and the illegal gains therefrom shall be confiscated;
p.(None): however, it may be exempted from other administrative punishments.
p.(None):
p.(None): Article 82 Articles confiscated according to the provisions in the Drug Administration Law and in the Regulations shall
p.(None): be dealt with under supervision by drug regulatory departments in accordance with regulations.
p.(None):
p.(None): Chapter X Supplementary Provisions Article 83 The terms used in the Regulations are defined as follows:
p.(None): Drug quality attachment and other marks refer to approval documents for drug production, drug testing reports, drug
p.(None): packages, labels and insert sheets.
p.(None):
p.(None): New drugs refer to the drugs which have not been marketed within the territory of the People's Republic of China.
p.(None):
p.(None): Prescription drugs refer to the drugs that may only be purchased, dispensed or used with prescriptions by licensed
p.(None): doctors or licensed assistant doctors.
p.(None):
p.(None): Non-prescription drugs refer to the drugs announced by the drug regulatory department under the State Council which can
p.(None): be purchased or used by consumers upon their own judgment without prescriptions by licensed doctors or licensed
p.(None): assistant doctors.
p.(None):
p.(None): Pharmaceutical preparations of medical institutions refer to pharmaceutical preparations based on fixed prescriptions
p.(None): which have been dispensed upon approval by medical institutions according to their own clinical needs for their own
p.(None): use.
p.(None):
p.(None): Drug certification refers to the process through which drug regulatory departments inspect and evaluate the units
p.(None): engaging in research and development, production, distribution or use of drugs as to their compliance with
p.(None): corresponding requirements, and decide on whether to issue the corresponding certificates.
p.(None):
...
p.(None):
p.(None): Drug wholesalers refer to the drug distributors who sell the purchased drugs to drug manufacturers, drug distributors
p.(None): or medical institutions.
p.(None):
p.(None): Drug retailers refer to the drug distributors who sell the purchased drugs to consumers directly.
p.(None):
p.(None): Article 84 The term "drugs to be marketed in China for the first time" used in Article 41 of the Drug Administration
p.(None): Law refers to the drugs that are marketed for the first time in China by domestic or foreign drug manufacturers,
p.(None): including the same product manufactured by different drug manufacturers.
p.(None):
p.(None): Article 85 In the second paragraph of Article 59 of the Drug Administration Law, "drug manufacturers, drug distributors
p.(None): or their agents are prohibited from offering, under any pretence, money or things of value or other benefits to leading
p.(None): members, drug purchasers, physicians, or other related persons of the medical institutions where their drugs are used",
p.(None): the term "money or things of value or other benefits" refer to the illegitimate benefits provided by drug
p.(None): manufacturers, drug distributors or their agents to leading members, drug purchasers, physicians, or other related
p.(None): persons of the medical institutions for the purpose of influencing their acts in purchasing or prescribing drugs.
p.(None):
...
...
Searching for indicator substance:
(return to top)
p.(None): shall be conducted by a team of inspectors randomly selected from the database of GMP inspectors according to the
p.(None): regulations of the drug regulatory department under the State Council.
p.(None):
p.(None): Article 8 The valid term of a Drug Manufacturing Certificate is five years. To continue its drug production, the
p.(None): Certificate holders shall, six months prior to the expiry date of the Certificate, apply for the renewal of the Drug
p.(None): Manufacturing Certificate according to the regulations of the drug regulatory department under the State Council.
p.(None):
p.(None): Where a drug manufacturer terminates its drug production or is closed down, its Drug Manufacturing Certificate shall be
p.(None): withdrawn by the original certificate-issuing authority.
p.(None):
p.(None): Article 9 Any drug substance used by a drug manufacturer to produce drug products shall have a drug approval number or
p.(None): an import drug license or a pharmaceutical product license issued by the
p.(None):
p.(None): drug regulatory department under the State Council upon examination, with the exception of Chinese crude drugs and the
p.(None): prepared slices of Chinese crude drugs over which no control by approval number is exercised.
p.(None):
p.(None): Article 10 In accordance with the provisions in Article 13 of the Drug Administration Law, any drug manufacturer being
p.(None): entrusted with contract production of the drug shall have a GMP certificate corresponding to the contracted drug.
p.(None):
p.(None): No vaccines, blood products or other drugs specified by the drug regulatory department under the State Council may be
p.(None): contracted for production.
p.(None):
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.(None): municipality directly under the Central Government.
p.(None):
p.(None): Transfer allocation and use of special pharmaceutical preparations regulated by the drug regulatory department under
p.(None): the State Council, and the transfer allocation and use of pharmaceutical preparations dispensed by medical
p.(None): institutions among provinces, autonomous regions, or municipalities directly under the Central Government shall be
p.(None): subject to the approval by the drug regulatory department under the State Council.
p.(None):
p.(None): Article 25 Pharmacy personnel of medical institutions who check and dispense prescriptions shall be the pharmaceutical
p.(None): technicians whose qualifications are legally recognized.
p.(None):
p.(None): Article 26 When purchasing drugs, medical institutions shall keep authentic and complete records. In the purchase
p.(None): record shall be indicated the adopted name of the drug in China, dosage form, strength, batch number, date of expiry,
p.(None): manufacturer, supplier, purchase volume, purchase price, date of purchase and other items specified by the drug
p.(None): regulatory department under the State Council.
p.(None):
p.(None): Article 27 Drugs provided to patients by the medical institutions shall be within the scope of diagnoses and treatments
p.(None): and dispensed according to the prescriptions of licensed doctors or licensed assistant doctors.
p.(None):
p.(None): The scope of drugs purchased and provided to patients by family planning technical service institutions shall be in
p.(None): conformity with the scope of services approved and the drugs shall be dispensed according to the prescriptions of
p.(None): licensed doctors or licensed assistant doctors.
p.(None):
p.(None): The out-patient departments, clinics and other medical institutions, which are set up by individuals, may not purchase
p.(None): or provide drugs other than those commonly used and those for emergency treatment. The range and category of the drugs
p.(None): commonly used and those for emergency treatment shall be determined by the local administrative department for health
p.(None): of the people's government of the province, autonomous region, or municipality directly under the Central Government
p.(None): together with the drug regulatory department at the same level.
p.(None):
p.(None): Chapter V Control over Drugs
p.(None):
p.(None): Article 28 The institutions for non-clinical safety evaluation and study of drugs shall implement the Good Laboratory
p.(None): Practice for Non-Clinical Laboratory Studies (GLP) and the institution for drug clinical trial shall implement the Good
p.(None): Clinical Practice (GCP). The GLP and GCP shall be formulated by the drug regulatory department under the State Council
p.(None): through respective consultation with the administrative department of science and technology under the State Council
p.(None): and the administrative department for health under the State Council.
p.(None):
p.(None): Article 29 Clinical trials, manufacturing and importation of drugs shall be in conformity with the provisions in the
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.(None): activities carried out in the place for the said drug shall be discontinued.
p.(None):
p.(None): Article 78 Where the drug regulatory department finds that a drug advertisement is published without approval by the
p.(None): drug regulatory department of the people's government of the province, autonomous region or municipality directly under
p.(None): the Central Government, the drug regulatory department of the people's government of the province, autonomous region or
p.(None): municipality directly under the Central Government shall notify the organ in charge of advertising supervision and
p.(None): control to investigate and handle the matter in accordance with law.
p.(None):
p.(None): Article 79 Where anyone that, in violation of the provisions set forth in the Drug Administration Law and in the
p.(None): Regulations, commits any of the following acts shall be given heavier punishments by the drug regulatory department
p.(None): based on the extent of punishment set forth in the Drug Administration Law and in the Regulations:
p.(None):
p.(None): (1) passing narcotics, psychotropic substances, medicinal toxic drugs and radioactive pharmaceuticals off as other
p.(None): drugs or vice versa;
p.(None):
p.(None): (2) producing or selling counterfeit or substandard drugs of which the main users are pregnant or parturient women,
p.(None): infants and children;
p.(None):
p.(None): (3) producing or selling biological and blood products which are defined as counterfeit or substandard drugs;
p.(None):
p.(None): (4) producing, selling or using counterfeit or substandard drugs, thus inducing harmful results to people;
p.(None):
p.(None): (5) producing, selling or using counterfeit or substandard drugs again after being punished; or
p.(None):
p.(None): (6) refusing or evading supervision and inspection, or forging, destroying or concealing relevant evidentiary
p.(None): materials, or using sealed and seized articles without authorization.
p.(None):
p.(None): Article 80 Branches of drug regulatory departments shall have the authority to, according to the provisions in the Drug
p.(None): Administration Law and in the Regulations, give administrative sanctions such as warning, fine and confiscation of
p.(None): drugs illegally produced or marketed and illegal gains therefrom.
p.(None):
p.(None): Article 81 Where a drug distributor or medical institution dose not violate the relevant provisions in the Drug
p.(None): Administration Law and in the Regulations and has sufficient evidence to prove its unawareness that the drugs being
p.(None): sold or used are counterfeit or substandard drugs, the said drugs and the illegal gains therefrom shall be confiscated;
...
Health / patients in emergency situations
Searching for indicator emergencies:
(return to top)
p.(None):
p.(None): Article 22 The valid term of a Pharmaceutical Preparation Certificate for Medical Institution is five years. To
p.(None): continue dispensing pharmaceutical preparation, the medical institution shall, six months prior to the expiry date of
p.(None): the Certificate, apply for the renewal of the Pharmaceutical Preparation Certificate for Medical Institution according
p.(None): to the provisions of the drug regulatory department under the State Council.
p.(None):
p.(None): Where a medical institution terminates dispensing Pharmaceutical preparations or is closed down, its Pharmaceutical
p.(None): Preparation Certificate for Medical Institution shall be withdrawn by the original certificate-issuing authority.
p.(None):
p.(None): Article 23 To dispense pharmaceutical preparation, the medical institution shall submit the dossier and samples
p.(None): according to the provisions of the drug regulatory department under the State Council, and the pharmaceutical
p.(None): preparation may only be dispensed after being approved by the local drug regulatory department of the people's
p.(None): government of the province, autonomous region or municipality directly under the Central Government and being issued a
p.(None): pharmaceutical preparation approval number.
p.(None):
p.(None): Article 24 No pharmaceutical preparations dispensed by medical institutions may be marketed or marketed in disguised
p.(None): forms, nor may any advertisement of such pharmaceutical preparations be released.
p.(None):
p.(None): When major disasters, epidemic situations or other emergencies occur, or there is urgent need clinically but no supply
p.(None): of the needed drugs in market, the pharmaceutical preparations dispensed by a medical institution may be used by other
p.(None): designated medical institutions within a specified time limit, upon approval by the drug regulatory department under
p.(None): the State Council or by the drug regulatory department of the people's government of a province, autonomous region and
p.(None): municipality directly under the Central Government.
p.(None):
p.(None): Transfer allocation and use of special pharmaceutical preparations regulated by the drug regulatory department under
p.(None): the State Council, and the transfer allocation and use of pharmaceutical preparations dispensed by medical
p.(None): institutions among provinces, autonomous regions, or municipalities directly under the Central Government shall be
p.(None): subject to the approval by the drug regulatory department under the State Council.
p.(None):
p.(None): Article 25 Pharmacy personnel of medical institutions who check and dispense prescriptions shall be the pharmaceutical
p.(None): technicians whose qualifications are legally recognized.
p.(None):
p.(None): Article 26 When purchasing drugs, medical institutions shall keep authentic and complete records. In the purchase
p.(None): record shall be indicated the adopted name of the drug in China, dosage form, strength, batch number, date of expiry,
p.(None): manufacturer, supplier, purchase volume, purchase price, date of purchase and other items specified by the drug
...
Social / Child
Searching for indicator children:
(return to top)
p.(None):
p.(None): Article 78 Where the drug regulatory department finds that a drug advertisement is published without approval by the
p.(None): drug regulatory department of the people's government of the province, autonomous region or municipality directly under
p.(None): the Central Government, the drug regulatory department of the people's government of the province, autonomous region or
p.(None): municipality directly under the Central Government shall notify the organ in charge of advertising supervision and
p.(None): control to investigate and handle the matter in accordance with law.
p.(None):
p.(None): Article 79 Where anyone that, in violation of the provisions set forth in the Drug Administration Law and in the
p.(None): Regulations, commits any of the following acts shall be given heavier punishments by the drug regulatory department
p.(None): based on the extent of punishment set forth in the Drug Administration Law and in the Regulations:
p.(None):
p.(None): (1) passing narcotics, psychotropic substances, medicinal toxic drugs and radioactive pharmaceuticals off as other
p.(None): drugs or vice versa;
p.(None):
p.(None): (2) producing or selling counterfeit or substandard drugs of which the main users are pregnant or parturient women,
p.(None): infants and children;
p.(None):
p.(None): (3) producing or selling biological and blood products which are defined as counterfeit or substandard drugs;
p.(None):
p.(None): (4) producing, selling or using counterfeit or substandard drugs, thus inducing harmful results to people;
p.(None):
p.(None): (5) producing, selling or using counterfeit or substandard drugs again after being punished; or
p.(None):
p.(None): (6) refusing or evading supervision and inspection, or forging, destroying or concealing relevant evidentiary
p.(None): materials, or using sealed and seized articles without authorization.
p.(None):
p.(None): Article 80 Branches of drug regulatory departments shall have the authority to, according to the provisions in the Drug
p.(None): Administration Law and in the Regulations, give administrative sanctions such as warning, fine and confiscation of
p.(None): drugs illegally produced or marketed and illegal gains therefrom.
p.(None):
p.(None): Article 81 Where a drug distributor or medical institution dose not violate the relevant provisions in the Drug
p.(None): Administration Law and in the Regulations and has sufficient evidence to prove its unawareness that the drugs being
p.(None): sold or used are counterfeit or substandard drugs, the said drugs and the illegal gains therefrom shall be confiscated;
p.(None): however, it may be exempted from other administrative punishments.
p.(None):
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.(None): under the State Council upon review, the drug approval number, Import Drug License or Pharmaceutical Product License
p.(None): shall be withdrawn.
p.(None):
p.(None): Article 43 No contents involving prevention, treatment or diagnosis of human diseases shall be included in the package,
p.(None): label or insert sheet and the related promotional materials for promoting a non-drug product, except as otherwise
p.(None): provided by laws or administrative regulations.
p.(None):
p.(None): Chapter VI Control over the Packaging of Drugs
p.(None):
p.(None): Article 44 Immediate packaging materials and containers used by drug manufacturers shall fulfill the requirements for
p.(None): medicinal use and the standards for ensuring human health and safety, and be subject to registration upon approval by
p.(None): the drug regulatory department under the State Council.
p.(None):
p.(None): The drug regulatory department under the State Council shall be responsible for working out and issuing the measures
p.(None): for control over immediate packaging materials and containers, the product directories and the requirements and
p.(None): standards for medicinal use.
p.(None):
p.(None): Article 45 Packaging materials and containers selected for production of prepared slices of Chinese crude drugs shall
p.(None): accommodate to drug property. No prepared slices of Chinese crude drug may be marketed whose package fails to conform
p.(None): to regulations. A label shall be printed on or attached to the package of prepared slices of Chinese crude drug.
p.(None):
p.(None): On the label of prepared slices of a Chinese crude drug shall be indicated the name of the drug, grade/weight, origin
p.(None): of production, manufacturer, product batch number and production date; if the said drug is controlled by approval
p.(None): number, the drug approval number shall also be indicated.
p.(None):
p.(None): Article 46 The package, label and insert sheet of a drug shall be printed in accordance with the provisions in Article
p.(None): 54 of the Drug Administration Law and those formulated by the drug regulatory department under the State Council.
p.(None):
p.(None): The trade name of a drug shall conform to the provisions of the drug regulatory department under the State Council.
p.(None):
p.(None): Article 47 The immediate packaging materials and containers used by medical institutions for dispensing pharmaceutical
p.(None): preparations, as well as the labels and insert sheets, shall conform to the provisions in Chapter 6 of the Drug
...
Social / Women
Searching for indicator women:
(return to top)
p.(None): activities carried out in the place for the said drug shall be discontinued.
p.(None):
p.(None): Article 78 Where the drug regulatory department finds that a drug advertisement is published without approval by the
p.(None): drug regulatory department of the people's government of the province, autonomous region or municipality directly under
p.(None): the Central Government, the drug regulatory department of the people's government of the province, autonomous region or
p.(None): municipality directly under the Central Government shall notify the organ in charge of advertising supervision and
p.(None): control to investigate and handle the matter in accordance with law.
p.(None):
p.(None): Article 79 Where anyone that, in violation of the provisions set forth in the Drug Administration Law and in the
p.(None): Regulations, commits any of the following acts shall be given heavier punishments by the drug regulatory department
p.(None): based on the extent of punishment set forth in the Drug Administration Law and in the Regulations:
p.(None):
p.(None): (1) passing narcotics, psychotropic substances, medicinal toxic drugs and radioactive pharmaceuticals off as other
p.(None): drugs or vice versa;
p.(None):
p.(None): (2) producing or selling counterfeit or substandard drugs of which the main users are pregnant or parturient women,
p.(None): infants and children;
p.(None):
p.(None): (3) producing or selling biological and blood products which are defined as counterfeit or substandard drugs;
p.(None):
p.(None): (4) producing, selling or using counterfeit or substandard drugs, thus inducing harmful results to people;
p.(None):
p.(None): (5) producing, selling or using counterfeit or substandard drugs again after being punished; or
p.(None):
p.(None): (6) refusing or evading supervision and inspection, or forging, destroying or concealing relevant evidentiary
p.(None): materials, or using sealed and seized articles without authorization.
p.(None):
p.(None): Article 80 Branches of drug regulatory departments shall have the authority to, according to the provisions in the Drug
p.(None): Administration Law and in the Regulations, give administrative sanctions such as warning, fine and confiscation of
p.(None): drugs illegally produced or marketed and illegal gains therefrom.
p.(None):
p.(None): Article 81 Where a drug distributor or medical institution dose not violate the relevant provisions in the Drug
p.(None): Administration Law and in the Regulations and has sufficient evidence to prove its unawareness that the drugs being
p.(None): sold or used are counterfeit or substandard drugs, the said drugs and the illegal gains therefrom shall be confiscated;
p.(None): however, it may be exempted from other administrative punishments.
p.(None):
...
Economic / Economic/Poverty
Searching for indicator poor:
(return to top)
p.(None): of alteration; no approved items may be altered without approval. The original certificate-issuing authority shall make
p.(None): a decision within 15 working days from the date it receives the application. The applicant shall, by holding Drug
p.(None): Supply Certificate with the altered items, register the alteration with the administrative department for industry and
p.(None): commerce in accordance with law.
p.(None):
p.(None): Article 17 The valid term of a Drug Supply Certificate is five years. To continue its drug
p.(None):
p.(None): distribution, the Certificate holder shall, six months prior to the expiry date of the Certificate, apply for the
p.(None): renewal of the Drug Supply Certificate according to the provisions of the drug regulatory department under the State
p.(None): Council.
p.(None):
p.(None): Where a drug distributor terminates its drug distribution or is closed down, its Drug Supply Certificate shall be
p.(None): withdrawn by the original certificate-issuing authority.
p.(None):
p.(None): Article 18 Where there is no drug retailers at town or country fairs in remote areas with poor communications, the
p.(None): local drug retailers may, after obtaining approval from the local drug regulatory departments of the counties (or
p.(None): municipalities) and being registered with the administrative departments for industry and commerce, set up stores at
p.(None): the fairs to sell non-prescription drugs within the approved scope for drug distribution.
p.(None):
p.(None): Article 19 Drug manufactures, drug distributors and medical institutions engaged in on-line drug transaction through
p.(None): the Internet and the drugs so transacted shall be in conformity with the provisions of the Drug Administration Law and
p.(None): in the Regulations. The administrative measures for on-line drug distribution services shall be formulated by the drug
p.(None): regulatory department under the State Council together with the other relevant departments under the State Council.
p.(None):
p.(None): Chapter IV Control over Pharmaceuticals in Medical Institutions
p.(None):
p.(None): Article 20 To establish a pharmaceutical preparation unit in a medical institution, an application shall be submitted
p.(None): to the local administrative department for health of the people's government of the province, autonomous region or
p.(None): municipality directly under the Central Government, and, after being consented upon examination, be reported to the
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.(None): institutions among provinces, autonomous regions, or municipalities directly under the Central Government shall be
p.(None): subject to the approval by the drug regulatory department under the State Council.
p.(None):
p.(None): Article 25 Pharmacy personnel of medical institutions who check and dispense prescriptions shall be the pharmaceutical
p.(None): technicians whose qualifications are legally recognized.
p.(None):
p.(None): Article 26 When purchasing drugs, medical institutions shall keep authentic and complete records. In the purchase
p.(None): record shall be indicated the adopted name of the drug in China, dosage form, strength, batch number, date of expiry,
p.(None): manufacturer, supplier, purchase volume, purchase price, date of purchase and other items specified by the drug
p.(None): regulatory department under the State Council.
p.(None):
p.(None): Article 27 Drugs provided to patients by the medical institutions shall be within the scope of diagnoses and treatments
p.(None): and dispensed according to the prescriptions of licensed doctors or licensed assistant doctors.
p.(None):
p.(None): The scope of drugs purchased and provided to patients by family planning technical service institutions shall be in
p.(None): conformity with the scope of services approved and the drugs shall be dispensed according to the prescriptions of
p.(None): licensed doctors or licensed assistant doctors.
p.(None):
p.(None): The out-patient departments, clinics and other medical institutions, which are set up by individuals, may not purchase
p.(None): or provide drugs other than those commonly used and those for emergency treatment. The range and category of the drugs
p.(None): commonly used and those for emergency treatment shall be determined by the local administrative department for health
p.(None): of the people's government of the province, autonomous region, or municipality directly under the Central Government
p.(None): together with the drug regulatory department at the same level.
p.(None):
p.(None): Chapter V Control over Drugs
p.(None):
p.(None): Article 28 The institutions for non-clinical safety evaluation and study of drugs shall implement the Good Laboratory
p.(None): Practice for Non-Clinical Laboratory Studies (GLP) and the institution for drug clinical trial shall implement the Good
p.(None): Clinical Practice (GCP). The GLP and GCP shall be formulated by the drug regulatory department under the State Council
p.(None): through respective consultation with the administrative department of science and technology under the State Council
p.(None): and the administrative department for health under the State Council.
p.(None):
p.(None): Article 29 Clinical trials, manufacturing and importation of drugs shall be in conformity with the provisions in the
p.(None): Drug Administration Law and in the Regulations, and shall be reviewed and approved by the drug regulatory department
p.(None): under the State Council. The drug regulatory department under the State Council may authorize the drug regulatory
p.(None): departments of the people's governments of the provinces, autonomous regions and municipalities directly under the
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): site is to be located. The drug regulatory department of the people's government of the province, autonomous
p.(None): region or municipality directly under the Central Government shall, within 30 working days from the date it
p.(None): receives the application, make a review according to the pharmaceutical industry development programs and policies
p.(None): issued by the State and make a decision on approval or disapproval.
p.(None):
p.(None): (2) After completion of establishment of the planned manufacturer, the applicant shall apply to the original approving
p.(None): department for acceptance inspection. The original approving department shall, within 30 working days from the date it
p.(None): receives the application, arrange an acceptance inspection according to the requirements for the establishment of such
p.(None): manufacturers set forth in Article 8 of the Drug Administration Law; a Drug Manufacturing Certificate shall be issued
p.(None): to the applicant if the inspection is passed. The applicant shall, by holding the Drug Manufacturing Certificate,
p.(None): register with the administrative department for industry and commerce in accordance
p.(None):
p.(None): with law.
p.(None):
p.(None): Article 4 Any drug manufacturer that intends to alter the approved items in the Drug Manufacturing Certificate shall,
p.(None): 30 days prior to the alteration of any approved items, apply to the original certificate-issuing authority for
p.(None): registration of alteration; no approved items may be altered without approval. The original certificate-issuing
p.(None): authority shall make a decision within 15 working days from the date it receives the application. The applicant shall,
p.(None): by holding the Drug Manufacturing Certificate with altered items, register the alteration with the administrative
p.(None): department for industry and commerce in accordance with law.
p.(None):
p.(None): Article 5 Drug regulatory departments at or above the provincial level shall organize inspection of drug manufacturers
p.(None): in accordance with the Good Manufacturing Practice for Pharmaceutical Products (GMP) and the measures and schedule for
p.(None): implementing the GMP formulated by the drug regulatory department under the State Council, and issue a certificate to
p.(None): the manufacturer that complies with the GMP. For the manufacturers producing injections and radioactive pharmaceuticals
p.(None): and for those producing biological products specified by the drug regulatory department under the State Council, the
p.(None): inspection of which shall be conducted by the drug regulatory department under the State Council.
p.(None):
p.(None): The format of GMP certificate shall be uniformly provided for by the drug regulatory department under the State
p.(None): Council.
p.(None):
p.(None): Article 6 Any newly-established drug manufacturer or manufacturer with newly-built drug manufacturing workshops or
...
p.(None): the date it receives the application, organize an inspection as to the compliance with the GMP requirements by the
p.(None): applying manufacturer. A certificate shall be issued to the manufacturer if the inspection is passed.
p.(None):
p.(None): Article 7 The drug regulatory department under the State Council shall set up a database of GMP inspectors. A GMP
p.(None): inspector shall be qualified as required by the drug regulatory department under the State Council. A GMP inspection
p.(None): shall be conducted by a team of inspectors randomly selected from the database of GMP inspectors according to the
p.(None): regulations of the drug regulatory department under the State Council.
p.(None):
p.(None): Article 8 The valid term of a Drug Manufacturing Certificate is five years. To continue its drug production, the
p.(None): Certificate holders shall, six months prior to the expiry date of the Certificate, apply for the renewal of the Drug
p.(None): Manufacturing Certificate according to the regulations of the drug regulatory department under the State Council.
p.(None):
p.(None): Where a drug manufacturer terminates its drug production or is closed down, its Drug Manufacturing Certificate shall be
p.(None): withdrawn by the original certificate-issuing authority.
p.(None):
p.(None): Article 9 Any drug substance used by a drug manufacturer to produce drug products shall have a drug approval number or
p.(None): an import drug license or a pharmaceutical product license issued by the
p.(None):
p.(None): drug regulatory department under the State Council upon examination, with the exception of Chinese crude drugs and the
p.(None): prepared slices of Chinese crude drugs over which no control by approval number is exercised.
p.(None):
p.(None): Article 10 In accordance with the provisions in Article 13 of the Drug Administration Law, any drug manufacturer being
p.(None): entrusted with contract production of the drug shall have a GMP certificate corresponding to the contracted drug.
p.(None):
p.(None): No vaccines, blood products or other drugs specified by the drug regulatory department under the State Council may be
p.(None): contracted for production.
p.(None):
p.(None): Chapter III Control over Drug Distributors
p.(None):
...
p.(None): shall be conducted by a team of inspectors randomly selected from the said database according to the provisions of the
p.(None): drug regulatory department under the State Council.
p.(None):
p.(None): Article 15 The State adopts a classification system for prescription drugs and non-prescription drugs. The State
p.(None): subdivides the non-prescription drugs into Class A drugs and Class B drugs according to the level of safety.
p.(None):
p.(None): Any drug retailer distributing prescription drugs or Class A non-prescription drugs shall have licensed pharmacists or
p.(None): other pharmaceutical technicians whose qualifications are legally recognized. Any retailer distributing Class B
p.(None): non-prescription drugs shall have pharmacy staff members who have passed the examination organized by the local drug
p.(None): regulatory institution of the municipality divided into districts or by the local drug regulatory institution at the
p.(None): county level which is directly set up by the drug regulatory department of the people's government of the province,
p.(None): autonomous region or municipality directly under the Central Government.
p.(None):
p.(None): Article 16 Any drug distributor that intends to alter the approved items in the Drug Supply Certificate shall, 30 days
p.(None): prior to the alteration of any approved items, apply to the original certificating-issuing authority for registration
p.(None): of alteration; no approved items may be altered without approval. The original certificate-issuing authority shall make
p.(None): a decision within 15 working days from the date it receives the application. The applicant shall, by holding Drug
p.(None): Supply Certificate with the altered items, register the alteration with the administrative department for industry and
p.(None): commerce in accordance with law.
p.(None):
p.(None): Article 17 The valid term of a Drug Supply Certificate is five years. To continue its drug
p.(None):
p.(None): distribution, the Certificate holder shall, six months prior to the expiry date of the Certificate, apply for the
p.(None): renewal of the Drug Supply Certificate according to the provisions of the drug regulatory department under the State
p.(None): Council.
p.(None):
p.(None): Where a drug distributor terminates its drug distribution or is closed down, its Drug Supply Certificate shall be
p.(None): withdrawn by the original certificate-issuing authority.
p.(None):
p.(None): Article 18 Where there is no drug retailers at town or country fairs in remote areas with poor communications, the
p.(None): local drug retailers may, after obtaining approval from the local drug regulatory departments of the counties (or
p.(None): municipalities) and being registered with the administrative departments for industry and commerce, set up stores at
p.(None): the fairs to sell non-prescription drugs within the approved scope for drug distribution.
p.(None):
p.(None): Article 19 Drug manufactures, drug distributors and medical institutions engaged in on-line drug transaction through
p.(None): the Internet and the drugs so transacted shall be in conformity with the provisions of the Drug Administration Law and
p.(None): in the Regulations. The administrative measures for on-line drug distribution services shall be formulated by the drug
p.(None): regulatory department under the State Council together with the other relevant departments under the State Council.
p.(None):
p.(None): Chapter IV Control over Pharmaceuticals in Medical Institutions
p.(None):
p.(None): Article 20 To establish a pharmaceutical preparation unit in a medical institution, an application shall be submitted
...
p.(None): Certificate for Medical Institution shall, 30 days prior to the alteration of any approved items, apply to the original
p.(None): reviewing and approving authorities for registration of alteration according to the provisions in Article 20 of the
p.(None): Regulations; no approved items may be altered without approval. The original reviewing and approving authorities shall
p.(None): make their own decisions within 15 working days from the dates they receive the application respectively.
p.(None):
p.(None): Any medical institution which intends to add new dosage forms or change dispensing sites shall, after passing the
p.(None): acceptance inspection by the local drug regulatory department of the people's government of the province, autonomous
p.(None): region or municipality directly under the Central Government, go through the registration of alteration of the
p.(None): Pharmaceutical Preparation Certificate for Medical Institution according to the provisions in the preceding paragraph.
p.(None):
p.(None): Article 22 The valid term of a Pharmaceutical Preparation Certificate for Medical Institution is five years. To
p.(None): continue dispensing pharmaceutical preparation, the medical institution shall, six months prior to the expiry date of
p.(None): the Certificate, apply for the renewal of the Pharmaceutical Preparation Certificate for Medical Institution according
p.(None): to the provisions of the drug regulatory department under the State Council.
p.(None):
p.(None): Where a medical institution terminates dispensing Pharmaceutical preparations or is closed down, its Pharmaceutical
p.(None): Preparation Certificate for Medical Institution shall be withdrawn by the original certificate-issuing authority.
p.(None):
p.(None): Article 23 To dispense pharmaceutical preparation, the medical institution shall submit the dossier and samples
p.(None): according to the provisions of the drug regulatory department under the State Council, and the pharmaceutical
p.(None): preparation may only be dispensed after being approved by the local drug regulatory department of the people's
p.(None): government of the province, autonomous region or municipality directly under the Central Government and being issued a
p.(None): pharmaceutical preparation approval number.
p.(None):
p.(None): Article 24 No pharmaceutical preparations dispensed by medical institutions may be marketed or marketed in disguised
p.(None): forms, nor may any advertisement of such pharmaceutical preparations be released.
p.(None):
p.(None): When major disasters, epidemic situations or other emergencies occur, or there is urgent need clinically but no supply
p.(None): of the needed drugs in market, the pharmaceutical preparations dispensed by a medical institution may be used by other
p.(None): designated medical institutions within a specified time limit, upon approval by the drug regulatory department under
p.(None): the State Council or by the drug regulatory department of the people's government of a province, autonomous region and
p.(None): municipality directly under the Central Government.
p.(None):
p.(None): Transfer allocation and use of special pharmaceutical preparations regulated by the drug regulatory department under
...
p.(None): control to investigate and handle the matter in accordance with law.
p.(None):
p.(None): Article 79 Where anyone that, in violation of the provisions set forth in the Drug Administration Law and in the
p.(None): Regulations, commits any of the following acts shall be given heavier punishments by the drug regulatory department
p.(None): based on the extent of punishment set forth in the Drug Administration Law and in the Regulations:
p.(None):
p.(None): (1) passing narcotics, psychotropic substances, medicinal toxic drugs and radioactive pharmaceuticals off as other
p.(None): drugs or vice versa;
p.(None):
p.(None): (2) producing or selling counterfeit or substandard drugs of which the main users are pregnant or parturient women,
p.(None): infants and children;
p.(None):
p.(None): (3) producing or selling biological and blood products which are defined as counterfeit or substandard drugs;
p.(None):
p.(None): (4) producing, selling or using counterfeit or substandard drugs, thus inducing harmful results to people;
p.(None):
p.(None): (5) producing, selling or using counterfeit or substandard drugs again after being punished; or
p.(None):
p.(None): (6) refusing or evading supervision and inspection, or forging, destroying or concealing relevant evidentiary
p.(None): materials, or using sealed and seized articles without authorization.
p.(None):
p.(None): Article 80 Branches of drug regulatory departments shall have the authority to, according to the provisions in the Drug
p.(None): Administration Law and in the Regulations, give administrative sanctions such as warning, fine and confiscation of
p.(None): drugs illegally produced or marketed and illegal gains therefrom.
p.(None):
p.(None): Article 81 Where a drug distributor or medical institution dose not violate the relevant provisions in the Drug
p.(None): Administration Law and in the Regulations and has sufficient evidence to prove its unawareness that the drugs being
p.(None): sold or used are counterfeit or substandard drugs, the said drugs and the illegal gains therefrom shall be confiscated;
p.(None): however, it may be exempted from other administrative punishments.
p.(None):
p.(None): Article 82 Articles confiscated according to the provisions in the Drug Administration Law and in the Regulations shall
p.(None): be dealt with under supervision by drug regulatory departments in accordance with regulations.
p.(None):
p.(None): Chapter X Supplementary Provisions Article 83 The terms used in the Regulations are defined as follows:
p.(None): Drug quality attachment and other marks refer to approval documents for drug production, drug testing reports, drug
p.(None): packages, labels and insert sheets.
p.(None):
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| authority | Relationship to Authority |
| children | Child |
| drug | Drug Usage |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| family | Motherhood/Family |
| illegal | Illegal Activity |
| party | political affiliation |
| poor | Economic/Poverty |
| pregnant | Pregnant |
| property | Property Ownership |
| substance | Drug Usage |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| drug | ['substance'] |
| substance | ['drug'] |
Trigger Words
consent
protection
Applicable Type / Vulnerability / Indicator Overlay for this Input