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
- November 2022: CTIS Training Update - European Medicines Agency (EMA) updated the page Clinical Trials Information System: training and support on November 30, 2022, by adding a new version of the CTIS – Sponsor handbook (v3.0). The below sections were newly added in version 3.0 of the CTIS – Sponsor handbook: Section 3.5: Marketing Authorization Holder (MAH) group of users – This section gives … Continue reading "November 2022: CTIS Training Update"
- November 2022: CTIS Update for Organization Management System (OMS) Trouble Shooting Sessions - European Medicines Agency updated the event pages Organisation Management System (OMS) Trouble Shooting Session for CTIS users- October 2022 and OMS Trouble Shooting Session for CTIS users- November 2022 on November 29, 2022, with the following information: A video recording of the session held on October 2022 was made available. A Presentation from the session … Continue reading "November 2022: CTIS Update for Organization Management System (OMS) Trouble Shooting Sessions"
- November 2022: CTIS Update - European Medicines Agency updated the event page, Clinical Trials Information System (CTIS) bitesize talk: Notifications – Part 2 over the What’s New Section on November 23, 2022: The presentation for the CTIS bitesize talk held on November 23, 2022, is now available on the event page. It explains, in brief, different kinds of circumstantial events … Continue reading "November 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.