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:
- Drugs for Rare Diseases Statistics
- Regulatory Pathways for Drugs for Rare Diseases
- Gaps in Current Regulatory Pathways and Accessibility of Drugs for Rare Diseases
- Potential Next Steps to Improve Access and Consistency for Rare Disease Drugs Approvals
- 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