Regulatory Enrolment Process (REP) Pilot for Clinical Trials

Author: Bhavesh Patel

Health Canada intends to launch a pilot project for clinical trial regulatory activities on November 1, 2019. The pilot project will be called the Regulatory Enrolment Process.

The Regulatory Enrolment Process (REP) will assist 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 scope of this pilot project 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, including:

• Clinical Trial Applications (CTA)
• Clinical Trial Application Amendments (CTA-A)
• Clinical Trial Notifications (CTA-N)
• Pre-Clinical Trial Application consultation meetings (Pre-CTA)

Eligible sponsors are commercial entities 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

•    Send an email to request to participate to hc.eReview.sc@canada.ca, with the subject heading "REP Pilot Clinical Trials".

• Provide the following information with the email request:
         o Sponsor name
         o Contact information
         o Number of new and/or existing dossier(s) (clinical trial protocols) planned
         o Number of regulatory activities planned

Currently, Health Canada encourages 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 must commit to the following requirements, if selected, to participate in the REP Pilot:
• Participants must 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 must 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, you can contact a Health Canada representative at  hc.eReview.sc@canada.ca.

References:

Health Canada notice for “Regulatory Enrolment Process (REP) Pilot for Clinical Trials dated August 28, 2019

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