Regulatory Enrolment Process: Mandatory effective October 1, 2020
Author: Preetha Prabhu
On Mar. 30, 2020, Health Canada published a notice that as of October 1, 2020 use of the Regulatory Enrolment Process (REP) will be mandatory for 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 REP has been created by the Health Products and Food Branch (HPFB) to facilitate the use of single window for transmission of regulatory transactions in electronic format, also known as the common electronic submissions gateway (CESG). This will ensure transmission of regulatory transactions considerably faster and more efficient than courier services and which provides secure transmission of transactions which standard email does not offer.
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, 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.
How to use the REP
Although the use of REP will be mandatory beginning on October 1, 2020, Health Canada is highly recommending that sponsors familiarize themselves with the CESG requirements, REP templates and help instructions, as well as the process prescribed in the Guidance Document: The Regulatory Enrolment Process for Drugs for Human Use, as early as possible.
The process of registering for and setting up a CESG account, as well as obtaining a dossier identifier (ID) requires some 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.
For regulatory activities that are under review post October 2020, sponsors must ensure they are prepared to use the REP should they be required to file a response to a clarification request.
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.
Please note that the Regulatory Enrolment Process (REP) Guidance Document will be available upon request via email at: firstname.lastname@example.org.
Notice: Mandatory use of the Regulatory Enrolment Process (REP) as of October 1, 2020 (dated Mar. 30, 2020) https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process/notice.html