Updated Notice: Regulatory Enrolment Process (REP) Non-Functional Pilot for Clinical Trials
April 22, 2020
Our file number: 20-105985-576
Health Canada is requesting sponsor participation in the Regulatory Enrolment Process (REP) non-functional pilot for clinical trial regulatory activities.
What is REP?
The REP will help the clinical trial industry file their transactions to Health Canada electronically via the Common Electronic Submission Gateway (CESG) sponsors will be able to send transitions 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.
The 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.
The 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.
The REP pilot project for pharmaceutical and biologic human drug regulatory activities launched in February 2017 has concluded, and REP was implemented for these regulatory activities in August 2019.
The REP functional pilot project for Medical Devices started in June 2019.
Health Canada launched a non-functional REP pilot for clinical trial regulatory activities in November 2019. During the non-functional pilot, participants are asked to provide feedback on the REP guidance document and the REP templates in order to determine the feasibility for using the REP with Clinical Trial regulatory transactions. Note: Health Canada will not be accepting transactions with real regulatory data as part of the non-functional pilot.
A functional REP pilot will be initiated at a later date, determined by Health Canada, where we will accept clinical trial regulatory transactions using REP.
Participation Details for the Non-Functional REP Pilot for Clinical Trials
- Pilot start date: November 1, 2019
- The scope includes all Regulatory Activities and Transactions in eCTD and non-eCTD electronic only formats pursuant to Part C, Division 5 of the Food and Drug Regulations:
- Clinical Trial Application (CTA)
- Clinical Trial Application Amendment (CTA-A)
- Clinical Trial Notification (CTA-N)
- Pre-Clinical Trial Application consultation meeting (Pre-CTA)
- Sponsors that can participate are commercial companies conducting clinical trials. In the future, Health Canada will expand the scope to institutions (e.g. hospitals and research institutes).
How to request to participate
Sponsors may express their interest by:
- Sending an email to request to participate to hc.eReview.email@example.com, with the subject heading "REP Pilot Clinical Trials".
- Providing the following information with the email request:
- Sponsor name
- Contact information
For further information or questions on the REP Pilot, email: hc.eReview.firstname.lastname@example.org.
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