Notice: Regulatory Enrolment Process (REP) Pilot for Division 1 & Division 8 (human drugs) regulatory activities
October 4th, 2018
Our file number: 17-111107-35
Health Canada is pleased to request sponsor participation in the Regulatory Enrolment Process (REP) pilot for Division 1 and Division 8 (human drugs) regulatory activities in both eCTD and non-eCTD formats.
REP helps industry provide information related to company and dossier to Health Canada, in advance of the regulatory review process; this is currently being provided using the submission application forms. By using web-based templates to capture this data in a structured format, Health Canada can receive the information via the Common Electronic Submission Gateway (CESG), partially populate internal systems ahead of time, and automate certain procedures when a regulatory transaction is received.
The objective of REP is to implement a common intake approach which includes expanding the scope of the CESG to accept more regulatory transactions in various formats. Once fully implemented, REP will reengineer existing administrative processes to take advantage of the tools and capabilities of an electronic processing and review environment. It will introduce a consistent approach to collecting high quality structured information across multiple regulatory activity types.
The CESG provides sponsors the ability to send regulatory transactions electronically to Health Canada in a secure manner, with reduced transmission times. It has been in operation at Health Canada since February 2014, for a subset of regulatory activities in eCTD format. The scope of regulatory activities accepted via the CESG will continue to expand to include more regulatory transactions in eCTD and non-eCTD electronic-only formats. Refer to the Frequently Asked Questions - Common Electronic Submission Gateway (CESG FAQ) document for further details.
As Health Canada moves closer towards a common submission intake process to harmonize and improve its business processes and tools, companies are encouraged to stay informed, provide feedback and participate in upcoming pilot projects.
REP Pilot for human pharmaceuticals and biologics
- Target duration: October 1st, 2018 to March 30th, 2019.
- Scope: All Regulatory Activities and Transactions in scope of eCTD and non-eCTD electronic-only formats pursuant to:
- Part C, Division 1 of the Food and Drug Regulations (Application for Drug Identification Number (DINA), Application for Drug Identification Number - Biologic (DINB), Application for Drug Identification Number - Disinfectant Product (DIND), Application for Drug Identification Number - Category IV Product (DINF), Post-Authorization Division 1 Change (PDC), Post-Authorization Division 1 Change - Biologics(PDC-B)
- Part C, Division 8 of the Food and Drug Regulations
Regulatory activities for medical devices, veterinary medicine, clinical trial applications and master files will not be eligible for this pilot.
1. How to request for participation in the REP Pilot
- Sponsors must express their interest by providing:
- A written request to participate in the pilot, via email to hc.eReview.email@example.com, with the subject heading “REP Pilot human drugs”.
- The request should include the following information:
- sponsor name
- contact information
- number of new and/or existing dossier(s) planned
- number of Regulatory Activities planned
We encourage sponsors to submit their requests for participation by as soon as possible. All requests will be assessed, and participants will be selected based on the requirements below. Further instructions on how to use the REP will be provided to all participants.
2. Sponsors must commit to the following requirements, if selected, to participate in the REP Pilot:
- All participants without CESG accounts must obtain one as soon as possible.
- All REP XML files must be sent to, and received from, Health Canada via the CESG, as no other method of transmission will be accepted.
- Regulatory Transactions (< 10 GB), provided as part of the pilot must be sent via the CESG.
- Once a participant uses the REP for a dossier (drug product), they must continue to use the REP for all subsequent regulatory activities and transactions for that dossier.
- Health Canada may limit the number of dossiers enrolled per participant.
- The first transaction should be submitted before the end of the pilot.
Questions related to this notice should be directed via email to hc.eReview.firstname.lastname@example.org.
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