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.
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
- 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).
1. How to request to participate in the REP Pilot
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
- Number of new and/or existing dossier(s) (clinical trial protocols) planned
- Number of regulatory activities planned
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:
- Participants need to have a CESG account.
- Participants must send all transactions utilizing REP XML files to Health Canada via the CESG.
- Once a participant uses the REP for a dossier (clinical trial protocol), they need to continue to use the REP for all subsequent regulatory activities and transactions for that dossier.
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.firstname.lastname@example.org.
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