Mexico

Mexico

National Registry of Clinical Trials (RNEC)

Verified on September 9, 2021

Mexico has a clinical trials registry, National Registry of Clinical Trials (RNEC). RNEC is not a World Health Organization (WHO) recognized primary registry. The registry is available through the website of Federal Commission for the Protection against Sanitary Risk (COFEPRIS), the regulatory body of the Mexican government. Protocol registration on RNEC is mandatory. However, result posting is optional.

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
RNEC Mandatory National Database (includes Ethics Requirement) Sponsor Clinical Trial Application

Interventional

Phase 1-4;

Observational

Spanish
Registration and Results Requirements
Registry Activity Legal Requirement Timing
RNEC Registration

Yes

Within 5 working days after official authorization from COFEPRIS
Results

No

Not yet specified

Registry Updates


  • September 2021: What’s New on ClinicalTrials.gov - Below update was posted on ClinicalTrials.gov What’s New section on September 16, 2021: Webinar on ClinicalTrials.gov Modernization: Join us on October 7, 2021, from 1:30 to 2:00 p.m. ET for an update on the ClinicalTrials.gov modernization effort. Please register via the ClinicalTrials.gov webinar registration page to learn more about the modernization efforts and information on the anticipated … Continue reading "September 2021: What’s New on ClinicalTrials.gov"
  • September 2021: UK Regulatory Update - Implementation of UK HRA’s New Reporting Standards for Clinical Research As per the latest update from UK Health Research Authority, new reporting standards have been implemented to ensure that all researchers fulfill their responsibilities to make their research open and transparent. This is in line with the commitments set out in the Make it Public research … Continue reading "September 2021: UK Regulatory Update"
  • September 2021: Peru Update - A notification (PRESS RELEASE No. 005-2021-OGITT/INS) dated September 09, 2021, was published on the Peruvian Registry of Clinical Trials (REPEC) website on September 13, 2021. In context of the same: Due to preventive maintenance, services of the REPEC Version 2 System will be temporarily suspended as of Sunday, September 12, 2021. The services provided in … Continue reading "September 2021: Peru Update"

References


  1. Clinical Trial Review Process. Mexico | ClinRegs. https://clinregs.niaid.nih.gov/country/mexico#scope_of_assessment. Accessed March 14, 2019.
  2. Characteristics of the documentation of requests related to clinical protocols of bioequivalence in human beings (Homoclave COFEPRIS 04-010-B ). gob.mx. https://www.gob.mx/cms/uploads/attachment/file/149031/Caracter_sticas_de_los_Sometimientos_04-010-B.pdf. Published 2015. Accessed November 15, 2018.
  3. User manual for National Registry of Clinical Trials (RNEC), COFEPRIS Mexico. https://manualzz.com/download/5316086. Published March 2013. Accessed February 02, 2020.