Regulatory Enrollment Process and the Use of the Common Electronic Submission Gateway for Medical Devices

Author: Bhavesh Patel

Health Canada is considering a pilot of the Regulatory Enrolment Process (“REP”) using the Common Electronic Submission Gateway (“CESG”) for Medical Device applications in Summer 2018.

Beginning in April 2017, Health Canada stopped accepting paper copies of Medical Devices regulatory activities and related transactions. The recommended format for these transactions is “non-eCTD electronic-only”. Detailed guidance on filing regulatory activities can be found in the Guidance Document “Preparation of Drug Regulatory Activities in “Non-eCTD Electronic-Only”.

The REP is a set of activities to facilitate the provision of information to Health Canada regarding the company and licence applications in advance of the regulatory review process. By using a collection of web-based templates to capture metadata in a structured XML format, Health Canada can receive the information via the CESG, partially populate internal systems ahead of time, and automate certain procedures when a submission is received.

The REP is currently being piloted by Health Canada for certain products, such as pharmaceuticals and biologics, in eCTD format. The intent of the REP is to expand the scope of the CESG to accept non-eCTD electronic-only transactions. 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.

The CESG allows sponsors to send regulatory transactions electronically to Health Canada in a secure manner, with reduced transmission times and cost. It has been in operation at Health Canada since February 2014 for a subset of regulatory activities in eCTD format. Subsequently, the scope of regulatory activities accepted via the CESG will continue to expand to include non-eCTD electronic-only submissions for various product lines.

Thank you for reading Regulated Affairs, the CAPRA Blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Feel free to share our blog posts and join us on social media.

Reference:

1. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/notice-regulatory-enrolment-process-gateway-devices.html