On November 5, 2024, Health Canada released the Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations. According to the notice, effective immediately, the option for aligned reviews for Health Canada with health technology assessment organizations (HTAs), i.e., Canada’s Drug Agency (CDA) and l'Institut national d'excellence en santé et en services sociaux (INESSS), is available to all biological and pharmaceutical new drug submissions. The goals of aligned reviews are to reduce duplication and time lags between Health Canada market authorization and HTA recommendations, where possible.
The notice formalizes the timelines, process, and considerations for sponsors with qualifying drug submissions. Sponsors may opt in to the aligned review pathway at any stage. To do so, a sponsor must submit to Health Canada a completed consent letter template authorizing sharing of information.
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 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.