As we previously reported, agile licensing amendments to the Food and Drug Regulations and Medical Devices Regulations were registered on November 29, 2024. We are continuing to update our previous article to reflect new draft and final guidance documents, as they are released. The agile licensing amendments to the Food and Drug Regulations include provisions requiring risk management plans for certain human drugs (RMP provisions). Those amendments will come into force on April 1, 2027.
On February 24, 2025, Health Canada released the Submitting risk management plans guidance document. This guidance document explains when and how sponsors and market authorization holders submit RMPs and RMP updates over the course of the lifecycle of a drug. Drugs for human use (as defined in section 2 of the Food and Drugs Act) under the Food and Drug Regulations are within the scope of the principles and practices outlined in the document, including pharmaceutical drugs, biologic drugs and radiopharmaceutical drugs. The guidance document does not apply to veterinary drugs, natural health products, whole blood and blood components, or medical devices.
The guidance document, which reflects many of the policy elements in the agile licensing amendments, comes into effect on July 1, 2025. In the meantime, the previous guidance document published in June 2015 and the related supporting notices from August 2020 and November 2020 will remain in effect. Further changes to the guidance document are expected in fall 2026 to fully reflect the RMP provisions.
Health Canada has advised that it will not hold formal consultations on the RMP guidance documents, but may consider feedback received before April 1, 2026, by email to mhpdpolicy-politiquesdpsc@hc-sc.gc.ca.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.