Modernizing the framework for drug establishment licensing (phase I)

Drug Establishment Licensing Bulletin 122, December 14, 2021

Health Canada published a notice of intent on December 11, 2021. The notice describes a regulatory proposal that would modernize parts of the Food and Drug Regulations (FDR) and Medical Device Regulations (MDR) under the Food and Drugs Act.

Amending these regulations would strengthen our ability to provide efficient, effective and agile oversight of medical devices and drugs. These changes would also help us address initiatives outlined in the Health and Biosciences Review Roadmap related to compliance and enforcement.

We'll also be proposing more transformative updates to the drug establishment licensing (DEL) framework under the FDR. These changes are part of an initiative called "Modernizing Compliance and Enforcement Oversight for Drugs - Phase 2". The target date for pre-publication of Phase 2 in Canada Gazette, Part I, is the fall of 2023.

During this entire process, we will be providing information to and consulting with stakeholders.

To help you comment on the notice of intent, we are making available the following documents:

• Phase 1 Amendment Summary Table
• Cost Benefit Survey

The cost-benefit analysis survey will help Health Canada understand the impact of the proposed amendments to the FDR on recall reporting.

You may ask for these documents by emailing us at: prsd-questionsdspr@hc-sc.gc.ca.

Please complete the survey and return it and your comments to prsd-questionsdspr@hc-sc.gc.ca by February 11, 2022.