Notice: Regulatory Enrolment Process (REP) implementation and expansion of the scope for the Common Electronic Submissions Gateway (CESG)
June 21, 2019
Our file number: 19-112683 - 23
The Regulatory Enrolment Process (REP) Pharmaceutical and Biologic drugs pilot, which included participation from approximately twenty companies, will conclude in July 2019. Health Canada is pleased to announce that the assessment of the REP pilot was generally positive. Therefore, we will begin REP implementation in August 2019. The use of REP will be available for all regulatory activities for human drugs pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations.
The objective of REP is to implement a common intake approach, which includes expanding the scope of the Common Electronic Submissions Gateway (CESG) to accept regulatory transactions in non-eCTD format.
What is REP?
REP consists of a set of web-based templates used to collect information from industry related to their company, dossiers and regulatory activities or transactions by utilizing XML format. Currently, information is collected in Microsoft Word or PDF forms.
Why use REP?
Using REP XML files will allow transactions in non-eCTD format to be sent via the CESG. This enables industry to quickly and securely send regulatory transactions to Health Canada. Refer to the CESG information page on the Health Canada website for further details.
The REP templates have been developed using drop down lists, in lieu of the existing free text fields. These lists enable higher accuracy of information collected, as well as, the ability for automation of metadata into Health Canada systems.
Details on the voluntary use of REP for human Pharmaceutical and Biologic Drugs
REP implementation will commence in August 2019, and will be available to sponsors that are filing regulatory transactions in both eCTD and non-eCTD formats. Additional information regarding REP is available on the REP information page. The REP guidance document and links to the REP templates will be available on the information page by August 2019.
REP pilot projects for Medical Devices, Veterinary Drugs and Clinical Trial Applications regulatory activities will be launched in the future. Communications will be published on the REP information page regarding each product line.
- Once REP is used for a dossier for a drug product all subsequent transactions for that dossier must also use REP.
- The REP Company XML files must be sent to, and received from, Health Canada via the CESG.
- All regulatory transactions (< 10 GB) provided using REP (i.e. transaction includes an REP XML file) must be sent via the CESG.
Sponsors without CESG accounts who are interested in using REP should obtain one as soon as possible. Please refer to the CESG information page for details.
Although the use of REP will be voluntary beginning in August, sponsors are highly recommended to familiarize themselves with the templates and the process. Health Canada intends to make REP mandatory within a year from the implementation date.Questions related to this notice should be sent via email to hc.eReview.firstname.lastname@example.org.
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