January 2021: Peru Regulatory Update

New Version of Peruvian Registry of Clinical Trials (REPEC)

As per notification COMMUNICATED No. 001-2021-OGITT/INS, published on January 06, 2021, the National Institute of Health (INS) has developed a new version of the REPEC that facilitates the searches, visualization and registration of data related to clinical trials carried out in Peru, whose objective is to serve as a source of primary information regarding clinical studies with pharmaceutical type research products and medical devices.

The General Office for Research and Technology Transfer – OGITT is responsible for the Peruvian Registry of Clinical Trials – REPEC, which is an online information system developed in its first version in 2006, after new technological changes at a global level, the INS publishes a new version of REPEC, which can be accessed through the following link https://repec.ins.gob.pe/.

The content of the new REPEC conforms to the standards set in the international platform for clinical trials registries of the World Health Organization regarding content, quality, validity, access, technical capacity and administrative profiles.

As of January 01, 2021, all requests for procedures related to new clinical trials must be registered in this new virtual platform of REPEC. Short and instructive tutorial videos have been made available to help the users.

All Sponsors and OICs are encouraged to register in the new REPEC in order to provide them with their username and password so that they can make requests for new clinical trials.

For the presentation of any modification related to an active clinical trial, it must be presented in the previous version of the REPEC link.

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