Canada: Life Sciences, Biotechnology & Nanotechnology

As we previously reported, Health Canada consulted on the framework for clinical trials, including on the new Clinical Trials Regulations and draft and updated guidance documents. Health Canada has now published a What we heard overview of the results of the consultation.

The September NEWSletter also provides information about the PMPRB’s participation in past and future events, as well as NPDUIS research initiative and activities.

It builds on the CDA’s 2025 Position Statement on the Use of Artificial Intelligence and was adapted from guidance published by the United Kingdom’s National Institute for Health and Care Excellence (“NICE”). While the CDA does not prohibit the use of AI, its overall position is cautious: AI should generally supplement, not replace, established methods.

On July 24, 2026, Health Canada published the Final Report of the Pharmaceutical and Life Sciences Sector Task Force to the Ministers of Health and Industry. The Task Force was launched in March 2026 as a joint federal initiative of Health Canada and Innovation, Science and Economic Development Canada. The Task Force’s mandate was to support reliable and sustainable access to pharmaceutical products in Canada and identify made-in-Canada solutions that drive innovation, competitiveness and long-term growth in the life sciences sector.

Le 17 juin 2026, Santé Canada a publié le Règlement modifiant certains règlements pris en vertu de la Loi sur les aliments et drogues (pénuries et cessation de la vente de drogues et d’instruments médicaux) (le « Règlement modificatif »), qui apporte des modifications au Règlement sur les aliments et drogues (RAD) et au Règlement sur les instruments médicaux (RIM).

The Pharmaceutical and Life Sciences Sector Task Force has released its final report addressing Canada's challenges in medication access, regulatory processes, and life sciences competitiveness. The report examines structural issues including lengthy reimbursement pathways, underperforming clinical trial environments, and erosion of domestic investment, while proposing 39 recommendation areas to strengthen Canada's health sovereignty and industrial strategy.

The 2026 annual Bloom Burton & Co. Healthcare Investor Conference—Canada's premier international forum for healthcare companies and investors—was held in late April in Toronto.

Health Canada released a notice to industry on April 24, 2026, outlining that manufacturers must use the Regulatory Enrolment Process (REP) and Common Electronic Submission Gateway (CESG) for medical device transactions as of April 1, 2026. As we previously reported, manufacturers of medical devices could voluntarily use the REP and CESG for medical device regulatory transactions as of July 2024.

In January and February 2026, Health Canada released the Quarterly Report for Q2 2025-2026 (July through September 2025) and for Q3 2025-2026 (October through December 2025).