On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations (FDR) and the Medical Devices Regulations in the spring of 2022. The proposed amendments are intended to modernize the Canadian therapeutic product regulatory system at every stage of products’ lifecycles from authorization to post-market. The proposed amendments: 1) authorize the Minister of Health (the Minister) to impose terms and conditions on drug and medical device authorizations and to require a Risk Management Plan (RMP); 2) extend flexibilities currently in use for COVID-19 drugs to other drugs in specified circumstances (e.g., rolling submissions); and 3) modernize requirements for biologic drugs.
The following is a general summary of some of the highlights from the proposed amendments discussed in the Notice of Intent.
As part of Health Canada’s broader Regulatory Innovation Agenda, Health Canada is seeking to implement more agile and internationally-aligned regulatory approaches to support access to innovative health technologies while maintaining patient safety.
As we reported, since the beginning of the COVID-19 pandemic, Health Canada established emergency pathways to expedite review and approval of drugs and medical devices for use in relation to COVID-19 through Interim Orders. Health Canada intends to leverage and build upon those emergency pathways, as well as other existing policies and procedures, in updating the regulatory framework for drugs and medical devices.
- Terms and Conditions. The Minister would be able to impose terms and conditions on any human or veterinary drug, and on Class II, III, and IV medical devices, either at the time the drug or device has issued, or at any later time if a serious risk, emergency, or uncertainty has been identified. Terms and conditions would be imposed after discussions with the manufacturer and would obligate them to take steps to manage risks and resolve uncertainties. Any terms and conditions could be amended or removed at any time, if necessary.
- Risk Management Plan (RMP). An RMP summarizes the risks of a drug and the pharmacovigilance activities and other measures that a manufacturer puts in place to monitor and manage any identified risks. The proposed amendments require applicants to provide the Minister with an RMP as part of their application for a drug authorization for human use. The Minister may also request a RMP if there are significant uncertainties related to a drug’s risks and benefits, or if there are reasonable grounds to believe that a drug’s benefits, risks, and uncertainties significantly deviate from, or are no longer effectively managed by, its existing plan. Finally, RMPs would not be considered confidential business information – summary information on each new RMP would be published by the Minister.
- Rolling Submissions. Rolling submissions, which are currently in use for COVID-19 drugs, would be extended to other drugs, such as those which address significant new and emerging infectious diseases in Canada, or which treat, prevent, or diagnose serious or severely debilitating diseases or conditions. Generic drugs and biosimilars are not eligible for this application pathway.
- Biologic Drugs. Requirements for biologic drugs under Part C, Division 4 (Biologic Drugs) of the FDR would be modernized by repealing product or class specific requirements and replacing them with more generalized requirements which reflect current safety practices.
- Manufacturing Controls. Requirements relating to biologics’ starting and auxiliary materials, controlling the contamination of biologics, and biologics’ storage and transportation requirements would be replaced with more flexible conditions which apply more broadly.
- Standards. Individual standards for certain biologic drugs (e.g., insulin) would be repealed in favor of relying on the standards set out in Schedule B to the Food and Drugs Act. Where no Schedule B standard exists, or where the available standard is unusable, the amendments would allow for the use of an alternative standard.
- Lot release. At any time, the Minister would be able to request samples of biologic drug lots, or other non-commercially available materials, for testing purposes. The Minister would also have the ability to suspend the sale of an individual lot where there is evidence that it would present an unacceptable risk to Canadians’ health and safety, rather than suspend the drug’s authorization.
- Labelling. The amendments contemplate labelling flexibilities for special containers. Further, a statement indicating the approved storage conditions and appropriate safety statements for a biologic could be required on certain labels. Labels of biologic drugs derived directly from human or animal sources would need to indicate the species of origin. Finally, the amendments would also allow manufacturers of certain biologic drugs stockpiled for use in sporadic and infrequent emergency situations to indicate the drug’s expiry date by other means, rather than through a statement on the drug’s packaging.
- On-site Evaluations. The amendments would clarify that the Minister, when considering a submission, can evaluate the manufacturing as implemented at the site of manufacture and confirm the ability of the manufacturer to consistently produce a safe biologic drug.
Health Canada is accepting comments on the Minister of Health’s proposal to amend the FDR and the Medical Devices Regulations until October 28, 2021. Comments can be submitted electronically to the Office of Legislative and Regulatory Modernization at email@example.com, or by mail to the Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Health Canada, Address locator 3000A, Ottawa, Ontario K1A 0K9.
- Notice of intent to amend the Food and Drug Regulations and the Medical Devices Regulations to support regulatory agility
- Food and Drugs Act, R.S.C., 1985, C. F-27
- Food and Drug Regulations, C.R.C., c. 870
- Medical Devices Regulations, SOR/98-282
- Health Canada’s Regulatory Innovation Agenda