Health Canada has updated its Forward Regulatory Plan: 2022-2024, providing information on regulatory initiatives Health Canada aims to propose or finalize over the next two years. Some of the new and updated initiatives pertaining to the Food and Drugs Act are highlighted below:
- Regulations amending the Food and Drug Regulations (Improving Access to Generic Drugs): in 2019, Health Canada pre-published proposed amendments to the Food and Drug Regulations regarding differences in the form of the medicinal ingredient in a generic drug product eligible for submission under the abbreviated new drug submission (“ANDS”) pathway by introducing a regulatory definition for “therapeutically active component”. Most significantly, a generic drug having a different salt form of the medicinal ingredient in the Canadian reference product would be eligible for submission as an ANDS under the proposed Regulations. Further, the proposed Regulations streamline identifying and labelling practices of the medicinal ingredient content in drug products, and make amendments to the definition of “innovative drug” in the data protection provisions of the Food and Drug Regulations (see our previous article from 2019). Health Canada plans to publish the proposed changes in fall 2022.
- Regulations amending the Food and Drug Regulations (Agile Regulations for Licensing Drugs) and Regulations amending the Medical Devices Regulations (Agile Regulations for Licensing Medical Devices): as we previously reported, the Minister of Health provided notice of intent to amend the Food and Drug Regulations and the Medical Devices Regulations to support regulatory agility. According to the current update, the pre-publication of the proposed amendments for public comment for licensing drugs is expected to take place in fall 2022 and for licensing medical devices in spring 2023.
- Regulations Amending the Food and Drug Regulations - Export and Transhipments of Drugs: on June 8, 2022, the Federal Government published Regulations Amending the Food and Drug Regulations (Exports and Transhipments of Drugs), which comes into force on December 8, 2022. The amendments extend drug establishment licensing and Good Manufacturing Practices (GMP) requirements to persons conducting licensable activities with drugs solely for export. Additionally, the proposed amendments would also clarify that drugs in transhipment through Canada must be in bond.
Health Canada has also updated its Regulatory Stock Review Plan: 2022-2024, which is a public list and description of planned reviews of regulations that Health Canada is proposing within a two-year period. The Stock Review Plan overlaps with some of the above described initiatives.