On July 31, 2021, the Minister of Health provided notice of proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations. The amendments are planned for spring 2022 and are intended to modernize the regulatory system for drugs and medical devices, as described below.
- Terms and Conditions: The amendments will expand the Minister's ability to impose terms and conditions on the market authorization of drugs and medical devices.
- Risk Management Plans: The amendments will create a new requirement for applicants to provide the Minister with a Risk Management Plan (and to update it in some circumstances).
- Rolling submissions: The amendments will create an optional pathway for regulatory approval of drugs that permits manufacturers to file data on a rolling basis, beginning with the submission of an initial data package and a plan to provide outstanding data within a set period of time. This pathway, currently available for COVID-19 drugs, will be expanded to drugs that address "significant new and emerging infectious diseases in Canada" or "the treatment, prevention or diagnosis of serious or severely debilitating diseases or conditions".
- Modernizing requirements for biologic drugs: The amendments will repeal and/or replace several outdated requirements for biologic drugs, including relating to: biological starting and auxiliary materials, contamination or cross-contamination, storage and transport, outdated individual standards for biologic drugs, lot release, labelling, and on-site evaluation of manufacturing facilities.
Public consultation on the proposed amendments is open until October 28, 2021.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.