0A4F4F9BD490A749D5437F821CF06DF1
Regulations for Drug Safety Monitoring
https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=L0030050
http://leaux.net/URLS/ConvertAPI Text Files/B10331FFA183806195FDC592F13244C2.en.txt
Examining the file media/Synopses/B10331FFA183806195FDC592F13244C2.html:
This file was generated: 2020-08-23 05:48:01
| 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
Health / Drug Usage
Searching for indicator drug:
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p.(None): Search SEARCH
p.(None):
p.(None): : Location Home > Law > Article Content
p.(None): P
p.(None):
p.(None): Article Content
p.(None):
p.(None):
p.(None):
p.(None): Title Regulations for Drug Safety Monitoring CH
p.(None): Amended Date 2013-11-21
p.(None): Category Ministry of Health and Welfare
p.(None):
p.(None):
p.(None): Article Content Article No Search Content Search Legislative History
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Article 1
p.(None): This set of Regulations is formulated in accordance with regulations of Paragraph 2, Article 45 of the Pharmaceutical Affairs Act.
p.(None):
p.(None): Article 2
p.(None): This set of Regulations applies to the following:
p.(None): 1. New medicines mentioned in Article 7 of the Pharmaceutical Affairs Act;
p.(None): 2. Medical devices designated by announcement of the Ministry of Health and Welfare, Republic of China (hereafter referred to as the
p.(None): Ministry);
p.(None): 3. Medicines designated to have a risk management plan by announcement or approval of the Ministry;
p.(None): 4. Medicines designated to have a post marketing clinical trial by the approval of the Ministry;
p.(None): 5. Other cases deemed applicable by announcement of the Ministry.
p.(None):
p.(None): Article 3
p.(None): The safety monitoring period of each medicament mentioned in the preceding Article as follows:
p.(None): 1. The period of Subparagraph 1 shall be five years from the date of the issuance of licenses;
p.(None): 2. The period of Subparagraph 2 shall be three years from the date of the issuance of licenses;
p.(None): 3. The period of Subparagraph 3 and 4 shall be approved or announced by the Ministry;
p.(None): 4. The period of Subparagraph 5 shall be announced by the Ministry.
p.(None): The monitoring period mentioned in the preceding paragraph may be extended by the Ministry if necessary.
p.(None):
p.(None): Article 4
p.(None): The manufacturer or importer of the medicament mentioned in the Subparagraph 1, 2 and 5 of Article 2 shall collect its safety
p.(None): information on drug use available both domestically and abroad during the safety monitoring period. In addition to making report
p.(None): following the Regulations Governing the Reporting of Severe Adverse Reactions of Medicines, periodic safety update report shall be
p.(None): fulfilled according to the format announced by the Ministry and submitted to the Ministry within the specified time period.
p.(None): The manufacturer or importer of the medicine mentioned in the Subparagraph 3 of Article 2 shall conduct announced or approved risk
p.(None): management plan, and submit the tracking reports to the Ministry within the specified time period.
p.(None): The manufacturer or importer of the medicine mentioned in the Subparagraph 4 of Article 2 shall submit the clinical trial report to the
p.(None): Ministry within the specified time period.
p.(None): If personal information for the reports mention in the preceding three paragraphs need to be collected and processed by the firms, the
p.(None): personal information shall be collected, processed and used according to Medical Care Act, Personal Information and Protection Act
p.(None): and its related provisions.
p.(None):
p.(None): Article 5
p.(None): For new drugs that have completed clinical trials or bridging studies in country and have been approved by the Ministry, during the
p.(None): period of safety monitoring of new drugs, medical care institutions may not ask for the clinical trials or trial use of individual drug. This
p.(None): regulation does not apply to the laboratory testing for acceptance of products.
p.(None):
p.(None): Article 6
p.(None): This set of Regulations shall be implemented on the day of announcement.
p.(None):
p.(None):
p.(None):
p.(None): News Law Convention
p.(None): Searching Justices of the Constitutional Court
p.(None):
p.(None):
p.(None): E-PAPER
p.(None): enter your email address
p.(None):
p.(None):
p.(None): Subscribe
p.(None):
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p.(None): Unsubscribe
p.(None):
p.(None):
p.(None): This website does not provide legal counseling service, please contact with related public offices for more information.
p.(None): In case of any discrepancy between the English version and the Chinese version, the latter shall prevail.
p.(None):
p.(None):
p.(None): │ Government Website Open Information Announcement │ Declaration on Privacy Right Protection │ Information Security Policy │ EMail │
p.(None): OPERATING BY THE WORKING GROUP OF THE R.O.C LAWS & REGULATIONS DATABASE, MINISTRY OF JUSTICE.
p.(None): NO. 130, Sec. 1, Chongqing S. Rd., Taipei, 10048, Taiwan(R.O.C.)
p.(None): Service Phone-Call: +886-2-2191-0189
...
Social / Property Ownership
Searching for indicator home:
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p.(None): Search SEARCH
p.(None):
p.(None): : Location Home > Law > Article Content
p.(None): P
p.(None):
p.(None): Article Content
p.(None):
p.(None):
p.(None):
p.(None): Title Regulations for Drug Safety Monitoring CH
p.(None): Amended Date 2013-11-21
p.(None): Category Ministry of Health and Welfare
p.(None):
p.(None):
p.(None): Article Content Article No Search Content Search Legislative History
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Article 1
p.(None): This set of Regulations is formulated in accordance with regulations of Paragraph 2, Article 45 of the Pharmaceutical Affairs Act.
p.(None):
p.(None): Article 2
p.(None): This set of Regulations applies to the following:
p.(None): 1. New medicines mentioned in Article 7 of the Pharmaceutical Affairs Act;
p.(None): 2. Medical devices designated by announcement of the Ministry of Health and Welfare, Republic of China (hereafter referred to as the
p.(None): Ministry);
p.(None): 3. Medicines designated to have a risk management plan by announcement or approval of the Ministry;
p.(None): 4. Medicines designated to have a post marketing clinical trial by the approval of the Ministry;
p.(None): 5. Other cases deemed applicable by announcement of the Ministry.
p.(None):
p.(None): Article 3
p.(None): The safety monitoring period of each medicament mentioned in the preceding Article as follows:
p.(None): 1. The period of Subparagraph 1 shall be five years from the date of the issuance of licenses;
p.(None): 2. The period of Subparagraph 2 shall be three years from the date of the issuance of licenses;
p.(None): 3. The period of Subparagraph 3 and 4 shall be approved or announced by the Ministry;
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| drug | Drug Usage |
| home | Property Ownership |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
justice
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input