March 2022: Peru Regulatory Update

Peruvian Registry of Clinical Trials (REPEC) published a notification (Press release No. 007-2022-OGITT/INS) on March 15, 2022. This details the measures established for the reception of documents by Documentary Procedure (TD) in a virtual and face-to-face manner.

Submissions and Inquiries via Email:

  1. Submission of TD requests, related to all types of new or ongoing clinical trials, not related to COVID-19 can be processed through [email protected].
  2. Inquiries and submission of applications for processing of clinical trials related to COVID-19 can be sent through [email protected].
  3. Inquiries related to all types of clinical trials, new or in progress, not related to COVID-19 can be sent through [email protected].

General Office of Research and Technology Transfer (OGITT) In-person Attention Table:

In-person assistance will be available through the OGITT Documentary Processing Office, Monday through Friday from 08:00 am to 04:15 pm. Address: National Institute of Health, Jirón Cápac Yupanqui 1400, Jesús María, Peru.

Phone numbers for various types of inquiries are also shared:

  1. For inquiries about files: (511) 748 1111 Annex 2155 and 2201
  2. For monitoring of Clinical Trials: 51(1) 748-1111, extension 2191 or Cell 975445205
  3. For inquiries about REPEC: Tel. 478 1111 annex 2616 Cel. 984108368

For receipt of documents and response by TD:

All requests must be addressed to the General Directorate of the OGITT-INS, and must expressly and specifically indicate the reason for the request. The lifting of the observations issued by the OGITT must be uploaded through the Peruvian Registry of Clinical Trials – REPEC and be notified by email at [email protected], in order to have traceability in monitoring their procedures.