Updates To Health Canada's Regulatory Initiatives For 2022-2024, And Amendments To Food And Drug Regulations (Exports And Transhipments Of Drugs)

Update: Health Canada's " Forward Regulatory Plan: 2023-2025" no longer lists some of the below initiatives, including the 2019 proposed amendments to the Food and Drug Regulations, "Regulations amending the Food and Drug Regulations (Improving Access to Generic Drugs)" (our previous article). We have been advised that the proposed amendments, as well as the 2021 to the proposed amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations Amending the Patented Medicines (Notice of Compliance) Regulations) (our previous article), are on hold.

New initiatives:

• Advanced Therapeutic Products Pathway for Adaptive Machine Learning-enabled Medical Devices: Health Canada is proposing to add a description of Adaptive Machine Learning-enabled Medical Devices to Schedule G, allowing these devices to be regulated as Advanced Therapeutic Products. These devices would be the first Advanced Therapeutic Products to be listed in Schedule G, a schedule added when new authorities were added to the Food and Drugs Act in 2019. These new authorities are intended to enable the use of customized regulatory requirements to allow for the agility and flexibility necessary to determine the appropriate oversight of innovative health products. See also our article, Health Canada paving the way for more AI/ML medical devices, for a discussion of steps Health Canada is taking to better support digital health technologies, including a discussion of the guiding principles identified by Health Canada, the FDA and the UK MHRA for Good Machine Learning Practice.
• Amendment to the Fees in Respect of Drugs and Medical Devices Order (Natural Health Products Fee Proposal): Health Canada is proposing to extend the existing Fees Order to include the evaluation of applications of natural health products, the issuance of site licences, and the right to sell natural health products in Canada.

Updated initiatives:

• 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.