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 time for completion of the clinical trial, the sponsor must submit the documents as established in Article 80 of the Clinical Trials Regulations approved by Supreme Decree No. 021-2017-SA within 30 calendar days prior to the end of the validity of the clinical trial.

This is not added as new information, it is a part of the existing regulation.

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