Recently, Health Canada announced that the Regulatory Enrolment Process (REP) will be mandatory to use as of October 1, 2020. The Health Products and Food Branch (HPFB) will be implementing this single window for transmission of regulatory transactions in electronic format replacing the existing Health Canada 3011: Drug Submission Application Form and the Drug Submission- Application Fee Form for Human and Disinfectant Drugs. This new process will be more time efficient as it avoids delays in courier services and allows faster data entry both by the sponsor and internally within Health Canada. As well, this new process will allow better security. This process will be mandatory for the regulatory processing of pharmaceutical, biologic and radiopharmaceutical drugs for humans. It will also be mandatory for disinfectants, pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations. Although it is not mandatory, it is encouraged that sponsors use REP for clinical trials, veterinary drugs, and medical devices.
The REP information will be sent to the HPFB via the Common Electronic Submissions Gateway (CESG) – similar to FDA drug submissions. XML format will be used and is ideal for Health Canada as it will minimize errors and therefore will improve consistency and reliability of the information captured. This new approach also eliminates the need for media such as CDs and DVDs. The template for the REP will aid in easier and faster data entry with drop down lists and predictive text.
Through the REP template, HPFB will collect routing IDs that will be used for two-way secure communication which will allow for quicker communication. The steps to beginning this process can be found here. As well, information on obtaining a dossier ID or obtaining a dossier from non-eCTD to eCTD is available here. It should be noted that the dossier is considered the REP dossier upon receipt of first transaction including a REP Regulatory Transaction XML file, afterwards the REP dossier must be provided using the REP company template. Health Canada recommends the familiarization of the Guidance Document: The Regulatory Enrolment Process for Drugs for Human Use and beginning the process of registering and setting up a CESG account and obtaining a dossier identifier as soon as possible, as this may take some time.
For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA