Mexico

Mexico

National Registry of Clinical Trials (RNEC)

Verified on June 24, 2022

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


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.