As previously reported, Health Canada announced in July 2021 its intent to amend the Food and Drug Regulations and the Medical Devices Regulations to modernize the regulatory system to permit agile licensing of drugs and medical devices. On December 17, 2022, the proposed amendments to both regulations were published for consultation: Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing). Amendments include:
- Terms and conditions: The amendments would expand the Minister of Health's ability to impose and enforce terms and conditions on the market authorization of drugs and medical devices, both before and after issuance.
- Risk management plans: The amendments would create a new requirement for applicants to provide a risk management plan for certain high-risk drugs, including those currently authorized, and all extraordinary use new drug submissions.
- Rolling review of submissions: The amendments would create an optional pathway for approval of certain eligible drugs that permits manufacturers to file data on a rolling basis.
- Assuring drug quality during manufacturing: The amendments would clarify requirements for the handling of drugs during manufacturing.
- Modernizing requirements for biologic drugs: The amendments would remove outdated product-specific requirements for biologic drugs and replace them with more general requirements.
- Disaggregated clinical trial data for new human drug submissions and supplemental new human drug submissions: The amendments would require a manufacturer to submit clinical trial data that is broken down by population subgroups, if the manufacturer has already submitted the data in this fashion to the US Food and Drug Administration or the European Medicines Agency.
Health Canada has also released for consultation new guidance documents to related to the proposed amendments, including:
- Guidance: Terms and conditions for medical devices
- Guidance on terms and conditions (T&Cs) for human and veterinary drugs
- Guidance on management of rolling reviews for drug submissions
- Biologic drugs (Schedule D drugs) – Division 4 proposed regulatory amendments (Notice only)
- Guidance on the collection and analysis of disaggregated data in clinical trials
- Guidance on the Food and Drug Regulations for public health emergency drugs
Health Canada is also seeking comments on proposed updates to the following existing guidance documents:
- Guidance: Labelling of pharmaceutical drugs for human use
- Quality (chemistry and manufacturing) Guidance: New Drug Submissions and Abbreviated New Drug Submissions
- Guidance: Submitting risk management plans
Consultation on the proposed amendments (via the Canada Gazette, Part 1) and guidance documents is open until March 27, 2023.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
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