2. General Questions
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2. General Questions
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2.1 Name of Regulatory Authority
Clinical trials are regulated in Mexico by the Federal Commission for the Protection Against Sanitary Risks (Comision Federal para la Protecciõn contra Riesgos Sanitarios (COFEPRIS).
2.2 Name of Ethics Committee
Mexico has a decentralized ethics process for the Research Ethics Committee (REC) operating through the National Bioethics Commission (Comision Nacional de Bioethica (CONBIOETICA)).
2.3 Clinical Trial Application Language
Spanish.
https://clinregs.niaid.nih.gov/country/mexico
2.4 Is regulatory approval required from both regulatory authorities and/or EC?
Yes, approval must be gained from both the ethics committee and COFEPRIS.
COFEPRIS is also responsible for authorizing the import of IPs. An applicant or the legal representative may submit a request to import an IP after COFEPRIS has approved the sanitary authorization request for drugs that are neither narcotic nor psychotropic, that do not have sanitary registrations, and that are intended for human research.
The applicant must be a resident of Mexico or have a legal representative submit an import request on the applicant’s behalf.
Foreign manufacturers must submit a license, a good manufacturing practices (GMP) certificate, or a document issued by the competent authority in the country of origin that proves the company has permission to manufacture drugs.
2.5 Can regulatory authority and EC submission be done in parallel?
No. Ethics approval must be gained prior to submitting an application to COFEPRIS.
https://clinregs.niaid.nih.gov/country/mexico#timeline_of_review
2.6 Requirement of any import permit/license before investigational product/study product is shipped from point of origin
Yes, there are three different types of import permits that may be issued for health products:
- Definitive import - authorizes the entry of products to remain in the national territory for an unlimited time.
- Temporary import - authorizes the entry of products for a limited time and with a specific purpose, with the understanding that they must return to the country of origin in a period not exceeding one year.
- Import in transit - authorizes the entry of products for their transfer from one national office to another, for their departure to leave the country, within a period not exceeding 30 days, and for sale or temporary distribution. The sale or distribution is authorized exclusively for medicines to be used for strategic purposes.
COFEPRIS is also responsible for authorizing the import of IPs. An applicant or the legal representative may submit a request to import an IP after COFEPRIS has approved the sanitary authorization request for drugs that are neither narcotic nor psychotropic, that do not have sanitary registrations, and that are intended for human research.
The applicant must be a resident of Mexico or have a legal representative submit an import request on the applicant’s behalf.
Foreign manufacturers must submit a license, a good manufacturing practices (GMP) certificate, or a document issued by the competent authority in the country of origin that proves the company has permission to manufacture drugs.
https://www.wipo.int/edocs/lexdocs/laws/es/mx/mx165es.pdf
2.7 Biological Specimen Export Requirements
Documentation needs to be submitted to COFERPRIS to apply for an export permit to export cells, tissues, and products of human beings and their components:
- Entry or Exit of Products of Human Beings form (see MEX-24).
- Proof of payment of rights in original and two legible copies.
- Letter of acceptance of the establishment abroad.
- A legible copy of the authorization document issued by COFEPRIS for the protocol when it is intended for humans, or a summary of the study when in vitro is being carried out, where appropriate.
- Copy of the operating notice or sanitary license
https://www.gob.mx/cms/uploads/attachment/file/652233/COFEPRIS-01-024.pdf
https://clinregs.niaid.nih.gov/country/mexico#specimen_import_&_export
2.8 Are studies of GMOs permitted (e.g., GMOs used in vaccines/vaccine manufacture and other modified products)?
Yes; Article 315 of the General Health Law was modified in 2015 and requires that all establishments obtain a license and authorization from COFEPRIS if they participate in the collection, conservation, analysis, preparation, supply, and disposal of organs, tissues, and cells.
There are currently no official Mexican Norms on the use of human stem and progenitor cells for therapeutic research purposes. However, regulation related to cell therapy has been developed by the National Center for Blood Transfusion.
2.9 Is in-country sponsor presence/representation required?
Yes, the sponsor must be located in the country.
2.10 Is there any mandatory requirement to identify a local PI or can a PI be based in a foreign country?
Yes. There must be a person locally responsible for the conduct of the trial.
2.11 Is there any mandatory requirement to identify a local chief or coordinating investigator?
No. Please refer to Section 2.10 above.
2.12 If the applicant is CRO or a third party, does regulatory authority need any authorization or transfer of obligations from the sponsor? Does the authorization letter need to be notarized and/or apostilled?
Yes, sponsors are permitted to delegate their responsibilities to a local CRO and this needs to be documented. However, there is no specific template. The letter does not need to be notarized or apostilled.
2.13 Is there a requirement to register clinical trials on a local registry or database?
Yes. Sponsors must register their trial into the National Registry of Clinical Trials (RNEC) within 5 days of approval.
https://clinregs.niaid.nih.gov/sites/default/files/documents/mexico/G-RNECManual_v1_Spanish.pdf
http://siipris03.cofepris.gob.mx/RegNacEnsClinicos/
2.14 What is the local requirement for clinical study documents archival; minimum of years for the archival, specific format followed (electronic/paper and/or both)?
All sponsor-specific essential documents (in any format) used in the trial should be retained for at least two years after the formal discontinuation of the trial or the last approval of a marketing application. The sponsor is also responsible for storing files related to the manufacture and control of the IP for at least five years after product registration has been granted. Additionally, the sponsor must ensure that this documentation is safeguarded and that the files are stored at the sponsor’s facilities or in specific facilities contracted for this purpose.
https://dof.gob.mx/nota_detalle.php?codigo=5424575&fecha=05/02/2016
http://academy.gmp-compliance.org/guidemgr/files/E6_R1_GUIDELINE.PDF
https://clinregs.niaid.nih.gov/country/mexico#product_management
2.15 Requirements around periodic safety reporting and timelines on SAEs/AEs/ADRs/SUSARs/DSURs.
Safety reporting must be submitted to the COFEPRIS’s National Pharmacovigilance Center (CNFV).
- SAEs must be reported within a maximum of seven of seven calendar days. Two or more serious cases, in the same cases, in the same place with the same drug and same batch, must be reported immediately, and no later than 48 hours.
- Non-serious AEs must be reported at the end of the study period.
- AEs or ADRs are to be reported within a maximum of 15 calendar days of first knowledge of the incident. Reports must be submitted when a drug shows a lack of effectiveness.
https://dof.gob.mx/nota_detalle_popup.php?codigo=5490830
https://dof.gob.mx/nota_detalle.php?codigo=5490830&fecha=19/07/2017#gsc.tab=0
https://clinregs.niaid.nih.gov/country/mexico#safety_reporting
2.16 Requirement on any periodic clinical study update, specific template, and its frequency (e.g., interim or annual progress report and final report, etc.)?
The PI must prepare and submit a progress report (also referred to as a partial technical or technical-descriptive report). The report can be submitted at any time, but at least once a year, to communicate progress and partial research results. The PI must also provide a copy of every report to the head of the Research Ethics Committee (REC).
The progress report should describe the results obtained and, at a minimum, should include the following elements:
- Identification data
- Materials and methods
- Results
- Conclusions
- Bibliographic references
- Any relevant exhibits
A report should be submitted annually during the first 10 business days of June.
The final report and results should include, at minimum, the following elements:
- Identification data
- Summary
- Introduction
- Materials and methods
- Results
- Discussion
- Conclusions
- Bibliographic references
- Any relevant exhibits/Annexes
https://dof.gob.mx/nota_detalle.php?codigo=5284148&fecha=04/01/2013#gsc.tab=0
2.17 Does the local regulation require notification of “serious breaches” of GCP or the trial protocol?
Yes. COFEPRIS must be notified of serious breaches of GCP.
2.18 Does RA/CA require insurance and indemnity to cover the sponsor and investigator’s potential liability?
Yes, the sponsor should provide insurance or should indemnify the investigator/the institution against claims arising from the trial, except for those claims arising from malpractice and/or negligence. A copy of the current Global Insurance Policy certificate delineating the financial or insurance funding for the study should be included with the protocol submitted in the application package.
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