Notice: Confirmation of the Mandatory use of the Regulatory Enrolment Process (REP) as of October 1, 2020
Date: July 6, 2020
Our file number: 20-1052634-535
By way of this update, Health Products and Food Branch (HPFB) is reminding sponsors that the mandatory date for use of the Regulatory Enrolment Process (REP) and the Common Electronic Submissions Gateway (CESG) is October 1, 2020 applicable to pharmaceutical, biologic and radiopharmaceutical drugs for human use as well as disinfectants, pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations.
The HPFB is implementing a single window for transmission of regulatory transactions in electronic format which is considerably faster and more efficient than courier services and which provides secure transmission of transactions which email does not offer. To facilitate the use of this single window, also known as the CESG, HPFB has created the REP.
What is the REP?
The REP is a method HPFB uses to collect information from sponsors related to their company, dossiers, products, regulatory activities and transactions. It consists of a set of web-based templates that upon completion generate REP Extensible Markup Language (XML) files. The REP XML files are sent to HPFB via the CESG.
The REP will replace the processes for the existing Health Canada 3011: Drug Submission Application Form and the Drug Submission - Application Fee Form for Human and Disinfectant Drugs.
Why use the REP?
The objective of the REP is to implement a common intake approach for all product lines, which includes the following:
- Sending all regulatory transactions using a single process. This will be achieved by eliminating the use of media (CDs, DVDs, etc.) and email transmission of transactions to HPFB and instead expanding the scope of the CESG to allow regulatory transactions in non-eCTD format.
- The web-based REP templates are designed to support easier and faster data entry for sponsors with the use of drop down lists, predictive text, help text, etc.
- Since the REP files sent by sponsors are in XML format, this will facilitate the upload of the data provided into internal Health Canada systems, enhancing accuracy, consistency and reliability of the information captured.
Scope of Mandatory REP
Mandatory filing of regulatory transactions using REP will apply to pharmaceutical, biologic, and radiopharmaceutical drugs for human use, as well as disinfectants pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations, that are filed in scope of either eCTD or non-eCTD format.
Sponsors are encouraged to use the REP for clinical trials, veterinary drugs, and medical devices. However, they are currently exempt from this mandatory requirement. Refer to the appropriate REP pilot project described on the REP information page for details.
How to use the REP
Although the use of REP will be mandatory beginning on October 1, 2020, it is highly recommended that sponsors submitting transactions to Health Canada (i.e. companies, consultants, etc.), familiarize themselves with the CESG requirements, REP templates, help instructions, as well as the processes prescribed in the Guidance Document: The Regulatory Enrolment Process for Drugs for Human Use, as early as possible. Detailed information regarding the REP is available on the REP information page.
The process of registering for and setting up a CESG account, as well as obtaining a dossier identifier (ID) requires some lead-time. Therefore, sponsors are encouraged to begin this process well in advance (e.g. approximately three months) of filing their first regulatory transaction using the REP and the CESG.
For regulatory activities that are under review after October 2020, sponsors must ensure they are prepared to use the REP should they be required to file a response to a clarification or deficiency.
Steps to complete, prior to filing a first regulatory transaction using the REP:
- Obtain a CESG account. Refer to the CESG information page for detailed instructions.
- Obtain a dossier ID. The dossier ID is a mandatory field on the REP Regulatory Transaction and Product Information templates.
- For a new dossier, the dossier ID can be requested using the appropriate form available on the REP information page.
- For an existing dossier that is being converted from non-eCTD to eCTD format, the dossier ID can be requested using the appropriate form available on the REP information page.
- For existing dossiers that will remain in non-eCTD format, the assigned dossier ID may found by checking on the Drug Submission Tracking System – Industry Access (DSTS-IA). Contact the Office of Submission and Intellectual Property at firstname.lastname@example.org for information on setting up a DSTS-IA account.
- Specific regulatory transactions may require a REP Product Information template to be completed. Refer to the Guidance Document: The Regulatory Enrolment Process for details on Product Information template requirements.
Important considerations about transitioning dossiers to REP
- A dossier is considered a “REP dossier” upon the receipt of the first transaction including a REP Regulatory Transaction XML file. After this, all subsequent transactions for that REP dossier must also be filed using the required REP XML files. Otherwise, they will be rejected.
- Once a company has at least one REP dossier, all their updates to company and contact information must only be provided using the REP Company template.
- All REP Company XML files and regulatory transactions (< 10 GB in size) provided using REP must be sent via the CESG.
Any transactions in scope of mandatory REP filed without the correct use of REP after the effective date of October 1, 2020, will not be accepted by Health Canada.
Questions related to this notice or general inquiries regarding the REP should be sent to hc.eReview.email@example.com
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