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CIRCULAR
FROM:
600-5776-14
DIRECTION OF MEDICINES AND BIOLOGICAL PRODUCTS
TO: CL STUDY SPONSORS (NICOS, CONTRACT RESEARCH ORGANIZATIONS
(OIC) AND INSTITUTIONS THAT DEVELOP RESEARCH WITH MEDICINES IN BEINGS
HUMANS.
SUBJECT: PROCESSES OF GOOD CLINICAL PRACTICES - PCB. DATE: DECEMBER 1, 2014
In the first instance, it is recalled that pursuant to Resolution 2378 of 2008, “By which the Good
Clinical Practices for the institutions that conduct research with medicines in human beings ", the
approval and interruption of clinical research protocols and activities will be in charge of the
National Institute for Food and Drug Surveillance Invima, according to the articles mentioned
then:
ARzicuLO s.- 'APPROVAL OF PROxEcros.- Clinical research projects may not be started
with drugs in humans, which are not approved by the National Surveillance Institute of
Medicines and Food - INVIMA, or that have not obtained a prior approval by said Institute ”.
a RícuLO 6 .- "INTERRUPTION OF INVESTIGATIONS. - The National Institute for Food and Drug Surveillance -
INVIMA, may at any time interrupt the performance of a clinical investigation or demand the
introduction of modifications to your project, in the following cases. ”
a) Alteration of the authorization conditions.
b) Breach of Good Clinical Practices.
c) Protection of human subjects test subjects.
d) Defense of public health.
PARAGRAPH.- The favorable or unfavorable results of each clinical investigation, whether it reaches its
order as if abandoned, must be reported to the National Institute of Food and Drug Surveillance -
INVIMA. ”
On the other hand, in response to the different requests related to the
evaluation and monitoring of research protocols, Invima requires specifying the
Institutions that provide Health Services (IPS) certified in Good Clinical Practice, the following:
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1. Regarding the evaluation procedure of clinical trials, what is related in the Guide for the
evaluation and monitoring of research protocols code PM01-RS- G45:
1.1 Approval of Protocols: As established in the guide, “The evaluation decision made
of the protocol (approval or not), will be notified to the sponsor through an administrative act issued
by the Directorate of Medicines and Biological Products (DMPB), where the
specific characteristics of the protocol, therefore it will not be possible to initiate research activities specific to the
protocol until such document is not available.
1.2 Phase IV Clinical Studies: Regarding Phase IV clinical trial protocols, they should only be submitted to
this Institute those clinical studies that present intervention in the study groups, such as
for example, trials with randomized treatments, which adopt the characteristics
from a clinical study.
1.3 Notification of deviations: It is recalled that the deviations presented during development
of the research protocols, must be notified only in Spanish language to
via email invimabpc@invima.gov.co in Excel format and at one time
maximum of 15 business days from when the Sponsor / CRO / OlC becomes aware, as
stated in the guide mentioned. All deviations must be reported, filed, as well as
those presented in phase IV studies with intervention.
1.4 Amendments to the protocol: In the cases in which an amendment is submitted, it requires the
update of the informed consent of the clinical study, the documents must be filed from
jointly.
All approvals of the amendments must be submitted simultaneously by the
ethics committees.
This type of procedure must be notified to the Group of Good Clinical Practices, who will assess the
relevance of the same and according to this evaluation will submit it to analysis by the Specialized Chamber of Medicines
and Biological Products.
When the amendment involves the safety of the research subject, it must be applied after approval by
part of the ethics committee and then submit to INVIMA. In these cases it is necessary that the committees
of ethics give priority to this evaluation.
1.5 Regarding the submission of Amendments, IPS, Informed Consents and investigators,
We inform that to date you must have authorization from INVIMA so that they can
be implemented and conducted, that is, that no IPS and Researcher may carry out a study without having
previously the authorization of this Institute, as well as the changes in the
informed consent or amendments, until these are reviewed and approved by INVIMA through
of the group of Good Clinical Practices.
PROSPERITY
IPARATODOS
600-5776-14
The sub-investigators must not be submitted to Invima, with the exception of those established in the “
GUIDE FOR THE SELECTION OF THE PRINCIPAL INVESTIGATOR ”Code. PM01-RS-G44.
2. Related to the Guide for medicines and clinical research supplies, code PM01-RS-G51.
Re-labeling processes:
As stated in the guide, re-labeling as a conditioning process
secondary must be done in a Pharmaceutical Laboratory that has a certificate in Good Practices of
Manufacturing, Logistics Operator centers that have Good Manufacturing Practices for
secondary conditioning or in Health Service Provider Institutions (IPS) that have Good
Elaboration practices for repackaging and / or repackaging processes. The above in accordance with the regulations
established national: Resolution 3183 of 1995, Resolution 3028 of 2008 and
Resolution 444 of 2008.
When the re-labeling is related to the extension of the product's shelf life in
research, it is recommended that requests be made with at least three
(3) months before the expiration of the product under investigation, in the same way it is recalled that according to
established by the World Health Organization for drug stability studies,
Colombia is classified as Climate Zone IV B. The presentation of the stability study
must be done with the tabulated results of natural stability of at least 2 batches of the
research product.
3. Related to the “Guide for the presentation of research protocols” Code PM01-RS-G36
Number 4. Guidelines for the presentation of literal research protocols h) Time of useful life
w / bow / act (Results of research product stability studies supporting life
and the certificate of analysis of the batch of the product with which the study will be carried out in the country).
It should be remembered that an investigational product is understood as a pharmaceutical form of a
active ingredient or placebo that is being tested or used as a reference in a clinical study,
including products with marketing authorization. When you submit a new protocol with
a new molecule that does not yet have a sanitary registry, it is necessary to include stability studies,
in the case of using placebo in the study, a certificate of analysis must be attached (minimum of two batches,
that includes microbial contamination, absence of active principle) less than 6 months after its completion.
When any medicine (with an approved health record or under investigation) that
it will be used or conditioned (formulated or packaged) in a different way from that approved or when
used to obtain more information about a previous use, the studies of
stability.
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600-5776-14
4. Related to the Guide annual report of research protocols Code: PM01-RS- G47, it is reported:
The annual report of each protocol must be submitted to Invima taking into account the date of approval of the study
clinic in the country, which corresponds until 2013, to the date of issue of the certificate issued by the
Review Commission where it recommends approving the protocol; as of 2014, it is considered as the date of
approval, the date of execution of the administrative act of approval issued by the DMPB. It is reiterated
that you have a maximum of 30 calendar days after the end of the approval year, to notify the
report.
Interested parties are reminded that those clinical studies that are active and take more than a year
since their approval, they must submit a single annual report listing all the information from the years of
protocol development.
5. It should be borne in mind that any submission involving drug research protocols
and related documents must be done in the updated formats, otherwise they will not be
evaluated and will be returned to the interested party.
These formats are available on the Invima website at the following links:
https://www.invima.qov.co/index.ühp?oütion=com content & view = articIe & id = 986: formats-
for-the-presentation-of-documents-related-to-research-protocols-qrupo-
of-good-clinical-practices-bpc & catid = 225: good-clinical-practices & ltemid = 381
https://www.invima.qov.co/index.php?option=com content & view = article & id = 994: report-
of-adverse-events & catid = 225: good-clinical-practices & Itemid = 385
https://www.invima.qov.co/index.php?option=com content & view = articIe & id = 2983% 3Ainfor
me-anuaI-de-protocoIos-de-investisacion & catid = 225% 3Abuenas-practices-clinics & Itemid = 326
All documentation submitted to Invima must be individually related, that is to say
the submission of each document must be separately and have its own filing number
(IPS, investigators, amendments, Informed Consents, among others).
6. Finally, the Directorate of Medicines and Biological Products recalls the rates found
established for processes related to clinical research, through Resolution No. 2014026516
of August 19, 2014. "By which the rates are updated in INVIMA", in which they were created and
updated referring rates with the processes of Clinical Trials and Good Clinical Practices,
demarcated below:
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^ PPRAORSAPTEORDIDOASD
600-5776-14
CODE 4010
4083
4089
CONCEPT
Visits to certify renew the Good Clinical Practices in the institutions where they are carried out
research with human beings, through the application and use of medications Evaluation of amendments to
pharmacological research protocols
Visit to verify new conditions in the certification of
Good Clinical Practices
DISCLAIMER:
Rate 4089 refers to visits to verify new conditions in the certification of Good Practices
Clinics of any of the base components and that have not been previously evaluated by this
Institute. This applies to:
• Change of headquarters of the research center
• Change or inclusion of the pharmaceutical service
• Change or inclusion of the clinical laboratory
• Change or inclusion of a new ethics committee
• Inclusion of a component of the certification in Good Clinical Practice All these rates apply from
from the date of publication of the R esolution.
This circular governs from the publication of the same.
Sincerely,
HEL NCO CHAPARRO LIGHT
Director of Biological Products and Products
Project: Professionals of the Clinical Trials Group - Special Programs VoBo Head of the Legal Advisory Office: R
Esteban Garcia
VoBo Special Pr Coordinator: A. Luna Legal VoBo D. Pulido
C.C .: External Consultation to ñb 2014