OBJECTIVES: The Canadian Organization of Rare Diseases (CORD) defines a rare disease as one that afflicts less that 1 person in 200 000. Significant market access and pricing challenges exist for ODs in Canada both at a federal and the provincial level. The scope of this study is to describe the ODs regulations in Canada, evidence requirements by the national regulatory agency, national and regional funding criteria, market access challenges associated with ODs, and approaches to obtain access to ODs in Canada. METHODS: Non-systematic PubMed search, Health Canada, the Canadian Agency for Drug and Technology in Health (CADTH), Common Drug Review (CDR), Canadian Organization of Rare Diseases (CODR) and different provinces Ministries of Health websites RESULTS: Health Canada reviews ODs to ensure that the drug meets the criteria of efficacy, safety, and manufacturing quality. The CDR conducts the clinical and cost effectiveness review compared to existing therapies and makes positive or negative recommendations to provinces to list ODs in their respective formularies. At the federal level, pricing of ODs is regulated by Patented Medicine Pricing Review Board (PMPRB). At the provincial level, different provinces can make their own independent reimbursement decision irrespective of CDR’s recommendation. Due to the large budget impact of ODs, most provinces do not provide access. The specialized access mechanism, criteria for eligibility, extent of coverage, and different data requirement to obtain access in three important provinces of Canada (Ontario, Alberta, and Quebec) will be discussed in the poster. CONCLUSIONS: In the absence of a national orphan drug policy, patients suffering from rare diseases face challenges in obtaining access to ODs in Canada. However, significant opportunities exist for manufacturers to provide access to ODs in Canada.