Health Canada’s National Strategy for Drugs for Rare Diseases

White Paper: Health Canada’s National Strategy for Drugs for Rare Diseases

Published August 2023

Abstract:


Canada's Minister of Health is continuing to work with provinces, territories, and stakeholders to establish a single national framework for drugs for rare diseases (orphan drugs).

This white paper explores:

  1. Drugs for Rare Diseases Statistics
  2. Regulatory Pathways for Drugs for Rare Diseases
  3. Gaps in Current Regulatory Pathways and Accessibility of Drugs for Rare Diseases
  4. Potential Next Steps to Improve Access and Consistency for Rare Disease Drugs Approvals
  5. Roundtable April 2022 - Proposed Draft Framework for National Strategy

Keywords: orphan drugs, rare diseases, drug approval, accelerated approval, priority status drug approval, special access program, clinical trials, regulatory, Health Canada, drug reimbursement, national strategy

Click here to view White paper: Health Canada’s National Strategy for Drugs for Rare Diseases