January 2021: Peru Regulatory Update

Update on New Version of Peruvian Registry of Clinical Trials (REPEC)

Peruvian Registry of Clinical Trials (REPEC) published a notification (COMMUNICATION N ° 002-2021-OGITT / INS) on January 28, 2021. In context of the new version of the REPEC, developed by the National Institute of Health (INS):

  • Any application for new registrations (Sponsor/OIC registration, Research Center registration, Ethics Committee registration, clinical trial authorization), must be made through the newly enabled REPEC Platform.
  • The previous REPEC platform will continue to record amendments, reports of adverse events, progress reports, deviations, among others, as well as changes in the conditions of authorization of clinical trials authorized until 2020, with the exception of clinical trials that have as a research product “vaccine candidates” which must use the new REPEC platform.

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