[PCN50] Comparison of the Trends of Orphan Drugs Designations and Approvals in the United States and Europe In Oncology
2016 Value in Health
Hanna, E. | Korchagina, D. | Toumi, M. |
Orphan drugs (OD) constitute a class of drugs that have been developed specifically to treat a rare medical condition referred to as “rare disease”. In January 1983, the United States (US) implemented the Orphan Drug Act (ODA). The European orphan drugs regulation was implemented almost 20 years after the US regulation, in 16 December 1999. Our objective is to compare the number of oncology orphan drugs designated and approved in the European Union (EU) and US.