Notice - The Regulatory Enrolment Process (REP) Functional Pilot for eCTD Format - Stage III

August 8, 2017

Notice

Our file number: 17-108825-143

In order to gain further experience with the regulatory enrolment process (REP) and to provide an opportunity for additional sponsors to begin using REP, Health Canada is announcing Stage III of the REP Functional Pilot for regulatory activities in electronic common technical document (eCTD) format.

The intent of this stage of the functional pilot for eCTD format is to increase the number of enrolments and transactions received from existing sponsors and to provide an opportunity for additional companies to get familiarised with REP.

The objective of the REP Functional Pilot is to assist Health Canada and sponsors to assess the feasibility of enrolling companies, dossiers, regulatory activities and regulatory transactions using REP. Lessons learned and experiences gained are continually being used to validate and improve the enrolment templates, enrolment process and the use of the REP files within a transaction in eCTD format.

Once fully implemented, the 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 metadata across multiple regulatory activity types.

REP Functional Pilot for eCTD Format

Sponsors are encouraged to request for participation promptly. All requests will be assessed, and participants will be selected based on the criteria below. Further instructions on how to use the REP will be provided to all participants at a future date.

Stage III of the REP Functional Pilot for eCTD format will commence in September 1st, 2017 and continue until February 28th, 2018.

Stages of the REP Functional Pilot
Pilot Stage I
(February 2017 - May 2017)
Stage II
(May 2017 - August 2017)
Stage III
(September 2017 - February 2018)
REP Scope
  • Only new Dossiers in eCTD format (i.e., New Drug Submission [NDS] and Abbreviated New Drug Submissions [ANDS])
  • Stage I scope; and
  • Regulatory Transactions in eCTD format for existing Dossier (i.e., Supplemental New Drug Submission [SNDS], Supplemental Abbreviated New Drug Submission [SANDS], Notifiable Changes [NC], etc.)
  • Stage II scope; and
  • All Regulatory Activities and Transactions in scope of eCTD formatFootnote *, including transactions pursuant to Part C, Division 1 of the Food and Drug Regulations (i.e.: Application for Drug Identification Number [DINA], Application for Drug Identification Number - Biologic [DINB], Post-Authorization Division 1Change [PDC], etc.)

Regulatory Activities and Transactions out of scope for eCTD format are also not eligible for this stage of the REP Functional Pilot.

1. How to request for participation in the REP Functional Pilot

  1. Existing participants as well as new Sponsors must express their interest by providing:
    • A written request to participate in the Stage III of the pilot, via email to eReview@hc-sc.gc.ca, with the subject heading "REP Functional Pilot for eCTD format - Stage III".
    • The request should include the following information:
      • Sponsor name;
      • Contact information;
      • Number of new and/or existing dossier(s) planned for Stage III;
      • Number of Regulatory Activities planned for Stage III.

The recommended deadline for submitting a request for participation is December 29, 2017.

2. Sponsors must commit to the following requirements, if selected, to participate in Stage III of the REP Functional Pilot for eCTD:

  • All REP XML files must be sent to, and received from, Health Canada via the Common Electronic Submissions Gateway (CESG), as no other method of transmission will be accepted.
  • Once a participant uses the REP for a dossier (drug product), they must continue to use the REP for subsequent regulatory activities and transactions, for that dossier.
  • Each participant will be limited to a maximum number of five (5) dossiers (drug products) during stage III of the pilot.

Note

Health Canada would like to provide an advanced notice for the consideration of March 1st, 2018 as a date for mandatory use of REP for regulatory activities, in eCTD format, that are pursuant to Part C, Division 8 (human drugs) of the Food and Drug Regulations.

Questions related to this Notice should be directed via email to eReview@hc-sc.gc.ca.

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