As we reported last month, the Minister of Health launched a consultation on a proposed Ministerial Reliance Order that would permit Health Canada to complete the examination of certain parts of a drug submission for new drugs by relying on decisions and documents made by foreign trusted regulators.
Health Canada has issued additional information for stakeholders regarding the proposed Ministerial Reliance Order. The additional information is intended to complement the draft Reliance Order and provides general information on how Health Canada proposes to interpret the requirements in the draft Reliance Order.
Further, the end of the consultation period has been extended to March 14, 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.