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 the previous version of REPEC (REPEC Version 1) will continue as normal.

Note: As of September 15, 2021, the registry website (Version 2) is not yet working.

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.

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 submitted through the Documentary Processing System of the National Institute of Health (INS).

  • Submission of requests for documentary processing related to all types of new or ongoing clinical trials, not related to COVID-19 can be processed through [email protected].
  • Consultations and submission of applications for processing clinical trials related to COVID-19 can be done using [email protected].
  • [email protected] should be used for consultations related to all types of clinical trials, new or running, not related to COVID-19.

Documents that were sent to the [email protected] mail, as of June 7, 2021, must be sent to the [email protected] mail.

All requests must be addressed to the General Directorate of the OGITT-INS with the specific reason for the request along with a descriptive title. An infographic of the notification is also made available here.

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.

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.