On Saturday, July 31st, 2021, Health Canada released a notice proposing targeted amendments to the Food and Drug Regulations and Medical Device Regulations as part of the Phase 1 of the Agile Regulation Licensing Drugs Initiative. The Agile Regulations are part of the Forward Regulatory Plan 2021-2023 of which Self-Care Framework is an element but not part of this proposal which is Phase 1. This is the first phase of the Agile Regulations.
The proposed Phase 1 Agile amendments consists of four main components:
- terms and conditions for all drugs and medical devices;
- rolling submissions for drugs;
- Risk Management Plans for higher risk drugs;
- repeal of certain outdated provisions respecting biologic drugs.
Health Canada is conducting a cost-benefit analysis (CBA) survey to assess the potential impact of the proposed measures which can be found below. Cosmetics Alliance will monitoring the progress of these regulation and if you have any points for consideration please let us know at regulatory@cosmeticsalliance.ca.
