Mexico

DCT Feasibility Assessment Mexico The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...

This guidebook provides an overview of the current and proposed regulatory landscape applicable in Mexico in relation to Decentralized Clinical Trials (“DCTs”). Clinical trials in Mexico are regulated by the Federal Commission for the Protection A...

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 ). https://www.gob.mx/cofep...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant. The following documentation must be submitted for ethics approval: Research protocol Protocol...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  The following documentation must be submitted to COFEPRIS as part of the approval process...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)? Mexico’s clinical trials comply with  ICH’s GCP .  Therefore, the investigator should be qualified by education, training, and e...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. The following general documentation must be provided to export cells, tissues, and products of human beings and their components: Entry or Exit...

7.1  Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? There are no regulations preventing the conduct of a DCT. 7.2  Is ther...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   The legal framework for data protection is found in Articles 6 and 16 of the Mexican Constitution , as well as in the...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ? There is no specific guidance on this matter. 9.2 Vulnerable Subjects...

10.1 Clinical Trial with Investigational Medicinal Product 10.2 Pediatric Investigation Plan (PIP) A PIP is not required. 10.3 Clinical Study (Interventional or Observational) COFEPRIS has lower expectations for observatio...

1. Mexican Regulatory Agency - https://www.gob.mx/cofepris   2. Language Requirements - https://clinregs.niaid.nih.gov/country/mexico   3. Regulatory and Ethics Approval Requirements - https://clinregs.niaid.nih.gov/sites/default/fi...

Notice of Suspected Adverse Drug Reactions (Spanish )