Submission to Health Canada Re: Draft Guidance (Accelerated Review of Human Drug Submissions)

The Accelerated Review of Human Drug Submissions guidance document sets out Health Canada’s approach to the review of new drug submissions and supplements to new drug submissions where prescription pharmaceutical, biologic (excluding biosimilars) or radiopharmaceutical drug product for human use for a serious, life-threatening or severely debilitating disease or condition.

Health Care Guidance on Rare Drug Evaluations.pdf