REGISTRY SNAPSHOT: Federal Commission for Protection Against Sanitary Risk (COFEPRIS)

by Staff writer,
Posted on 5/21/2019

Knowing which countries to submit clinical trial results summaries to is the easy part. What becomes difficult is learning the intricacies and transparency requirements of every clinical trial registry globally, including the Federal Commission for Protection Against Sanitary Risk (COFEPRIS). Here is an overview of this registry:

Registry name: Federal Commission for Protection Against Sanitary Risk (COFEPRIS)

Country: Mexico

Year established: 2001

Points of interest:

  • COFEPRIS—part of Mexico’s Ministry of Health—is responsible for overseeing regulatory framework in medicines
  • Any research involving humans must be approved by COFREPRIS. Some of the main requirements for an application for authorization include:
    • Approval by an independent ethics committee registered with the Ministry of Health
    • Approval by the medical institutions where the clinical trials will be conducted
    • Clinical trial protocol
    • An investigator’s letter
    • Written informed consent templates
  • There are currently efforts in place to reach international standards for clinical trial practices
  • The Health Law Regulations for Health Research and the Official Mexican Standard (NOM) for health research in human beings provide clinical trial reporting guidelines
  • The principal clinical researcher must write a final technical report for the clinical trial
  • Informed consent must be attained from all participants
  • View the Transparency section of the COFEPRIS website here

Related transparency research/articles:

TrialAssure REGISTRY can automate the disclosure of clinical trial results for COFEPRIS. For questions or a free demo, fill out this form.

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