Peru has a primary registry, Peruvian Clinical Trials Registry (REPEC) which has a provision to register a clinical trial. REPEC is a World Health Organization (WHO) recognized primary registry. It was developed in 2007 by the National Institute of Health (INS) and contains records of clinical trials since 1995. Information on all clinical trials submitted to the General Office for Research and Technology Transfer (OGITT) by the National Institute of Health (INS) and that has been authorized or not authorized to be executed in Peru is published on it.
| Registries at a Glance | |||||
| Registry | PHUSE Categorization | Information to be Entered By | Route of Data in Registry | Study Type | Language |
| REPEC | Mandatory National Database (includes Ethics Requirement) | Competent authority | Clinical Trial Application |
Interventional (Phase 1-4);Observational |
Spanish 
English |
| Registration and Results Requirements | |||
| Registry | Activity | Legal Requirement | Timing |
| REPEC | Registration |
Yes |
Prior to enrollment |
| Results |
No |
Not applicable (NA) | |
Registry Updates
- 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"
- July 2021: Peru Regulatory Update - The Peruvian Registry of Clinical Trials (REPEC) published a notification (PRESS RELEASE No. 004-2021-OGITT/INS) on July 23, 2021, as a reminder for the sponsors of clinical trials stating that the authorization of a clinical trial is granted for the total period of time scheduled for its execution. In this context, to request the extension of … Continue reading "July 2021: Peru Regulatory Update"
- June 2021: Peru Regulatory Update - Measures Established for the Receipt of Documents by Documentary Procedure Peruvian Registry of Clinical Trials (REPEC) published a notification (PRESS RELEASE No. 003-2021-OGITT/INS) on June 02, 2021. In context of the same: The General Office of Research and Technology Transfer (OGITT) has enabled the below emails to streamline the procedures regarding the receipt of documentation … Continue reading "June 2021: Peru Regulatory Update"
References
- Regulation of Clinical Trials Approved with Supreme Decree N° 021-2017-SA. Regulation of Clinical Trials. https://ensayosclinicos-repec.ins.gob.pe/images/REC-021-2017-sa-1538902-2.pdf. Published June 30, 2017. Accessed February 1, 2019.