As previously reported, Health Canada has proposed a Ministerial Reliance Order that would allow Health Canada to rely on decisions of foreign regulatory authorities (FRAs). Health Canada has proposed that the Reliance Order will come into force in summer 2026, at which point Health Canada will consult on an applicable guidance document.
The proposed Reliance Order contemplates a list incorporated by reference (IbR List) that would set out the classes of drugs and FRAs that fall within the scope of the Reliance Order. On May 5, 2026, Health Canada issued a notice requesting feedback on the proposed phased implementation process for developing and updating the IbR list. The proposed IbR list is broken down into Parts 1 and 2, as follows, and the Notice indicates which ‘phase’ would be applicable to which part:
1. Part 1, Subpart 1: General deeming of new drug submissions (NDS) and their supplements (SNDS) – Phase 1:
- Phase 1 would include “certain classes of drugs to address therapeutic gaps that have been previously identified, such as human drug classes with pediatric conditions of use. Additional information about which classes of drugs would qualify will be available at CGII.” Phase 2 would add further classes of drugs based on what is learned in Phase 1.
2. Part 1, Subpart 2: 120-day filing – Phase 2; addition of classes of drugs to this subpart will be considered via a targeted approach.
3. Part 1, Subpart 3: General deeming of abbreviated NDS (ANDS) and their supplements (SANDS) – Phase 3 (also applies to biosimilars).
4. Part 2, Joint reviews for NDS and SNDS – Phase 1 - four foreign regulatory authorities (FRAs) proposed (Singapore, Australia, Switzerland and the UK).
As part of the consultation, Health Canada is seeking feedback on:
- the proposed approach to developing and updating the IbR list,
- the proposed categories for inclusion in Phase 1, and
- considerations that should inform future phases of the IbR list.
The consultation is open until June 4, 2026.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group or the Pharmaceutical Litigation Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.