Canada | Notice of intent to amend the Food and Drug Regulations and the Medical Devices Regulations to support regulatory agility

Purpose: This notice is to inform Canadians, regulated parties and other stakeholders that Health Canada intends to amend the Food and Drug Regulations and the Medical Devices Regulations in the spring of 2022. The amendments would continue to modernize the Canadian therapeutic product regulatory system toward strengthened implementation of a lifecycle approach through continuous monitoring, assessment and communication of the risks and benefits of drugs and medical devices at both the authorization stage and once they are on the market. The amendments would give the Minister of Health (the Minister) the ability to impose terms and conditions on drug and medical devices authorizations as well as the ability to require a Risk Management Plan. The amendments would also extend flexibilities such as rolling submissions, which are currently in use for COVID-19 drugs, to other drugs in specified circumstances and would modernize requirements for biologic drugs by repealing outdated requirements and replacing them with those that reflect current safety practices.

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