Notice: Regulatory Enrolment Process (REP) Pilot for Clinical Trials

August 28, 2019
Our file number: 19-117117-387

Health Canada is pleased to request sponsor participation in the Regulatory Enrolment Process (REP) pilot for clinical trial regulatory activities.

What is REP?

REP will help the clinical trial industry file their submissions to Health Canada electronically. By using the Common Electronic Submission Gateway (CESG), sponsors will be able to send this information in a secure manner, with reduced transmission times and cost.

The CESG has been in operation at Health Canada since February 2014 for a subset of regulatory activities. Refer to Health Canada's Common Electronic Submission Gateway web page for more information.

REP will facilitate the filing and processing of information related to companies, dossiers, regulatory activities and regulatory transactions.

The expansion of the REP to clinical trials is part of a broader move towards a common submission intake across product lines.

REP consists of a set of web-based templates that capture sponsor provided information in a structured XML (Extensible Markup Language) format. This format uses pick lists and built-in logic, which help to increase the accuracy of information provided in the templates to support the regulatory review process.

REP Pilots

The REP pilot project for pharmaceutical and biologic human drug regulatory activities launched in February 2017 has concluded, and REP will be implemented for these regulatory activities in August 2019. A REP pilot project for Medical Devices started in June 2019. Health Canada intends to launch a pilot project for clinical trial regulatory activities in November 2019.

REP Pilot for Clinical Trials

1. How to request to participate in the REP Pilot

Sponsors may express their interest by:

We encourage sponsors to submit their requests for participation as soon as possible.

Health Canada will assess requests based on the requirements above. Further instructions on how to use the REP will be provided to all accepted participants.

2. Sponsors need to commit to the following requirements, if selected, to participate in the REP Pilot:

Throughout the pilot, Health Canada will be seeking feedback from participants on the new XML-based templates and processes.

For further information on the REP Pilot, email hc.eReview.sc@canada.ca.

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