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
- June 2022: Key Performance Indicators to Monitor European Clinical Trial Environment - European Medicines Agency updated the page, Clinical Trials Regulation: progress on implementation by adding ‘Key performance indicators (KPIs) to monitor the European clinical trials environment (1 – 31 May 2022, edition 2)‘ document over the What’s New Section on June 27, 2022: KPIs to monitor the European clinical trials environment: It is the second report … Continue reading "June 2022: Key Performance Indicators to Monitor European Clinical Trial Environment"
- June 2022: CTIS Update for Organization Management System (OMS) Trouble Shooting Sessions - European Medicines Agency updated about the upcoming events of Organisation Management System (OMS) Trouble Shooting Session for CTIS users to the What’s New Section on June 27, 2022: EMA will be hosting several OMS trouble shooting sessions on the following dates: July 21, 2022: 14.00 to 15.00 (CEST) September 22, 2022: 14.00 to 15.00 (CEST) … Continue reading "June 2022: CTIS Update for Organization Management System (OMS) Trouble Shooting Sessions"
- June 2022: CTIS Update - European Medicines Agency updated about the upcoming Clinical Trials Information System (CTIS) bitesize talks over the What’s New Section on June 27, 2022: EMA will host two bitesize talks, CTIS bitesize talks: Notifications – Part 1 and Notifications – Part 2 on September 28, 2022, and October 20, 2022, respectively. The sponsors will get an … Continue reading "June 2022: CTIS Update"
References
- Clinical Trial Review Process. Mexico | ClinRegs. https://clinregs.niaid.nih.gov/country/mexico#scope_of_assessment. Accessed March 14, 2019.
- 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.
- User manual for National Registry of Clinical Trials (RNEC), COFEPRIS Mexico. https://manualzz.com/download/5316086. Published March 2013. Accessed February 02, 2020.