Proposed changes to the Food and Drug Regulations and the Medical Devices Regulations would modernize the regulatory system for therapeutic products – food, drugs, health care, life sciences

Canada: Proposed Amendments to the Food and Drug Regulations and Medical Devices Regulations Would Modernize the Regulatory System for Therapeutic Products

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On July 31, 2021, the Minister of Health opinion of proposed amendments to the Food and Drug Regulations and the Regulation respecting medical devices. The changes are scheduled for spring 2022 and aim 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 marketing authorization of drugs and medical devices.
  • Risk management plans: The changes will create a new requirement for applicants to provide the Minister with a risk management plan (and update it in certain circumstances).
  • Continuous submissions: The changes will create an optional pathway for regulatory approval of drugs that will allow manufacturers to file data on an ongoing basis, starting with the submission of an initial data set and a plan to deliver the outstanding data in a specific timeframe. This route, currently available for COVID-19 drugs, will be extended to drugs that treat “important new and emerging infectious diseases in Canada” or “the treatment, prevention or diagnosis of serious or severely debilitating diseases or conditions” .
  • Modernization of requirements for biologics: The changes will repeal and / or replace several obsolete requirements for biological drugs, in particular concerning: starting and auxiliary biological materials, contamination or cross-contamination, storage and transport, obsolete individual standards for biological drugs, batch release, labeling and site assessment of manufacturing facilities.

Public consultation on the proposed changes is open until 28 October 2021.

If you have any questions, please do not hesitate to contact a member of the Life Sciences Regulation and Compliance group.

The above 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. For such advice, please contact our offices directly.

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