1. European Parliament and Council Regulation (EC) No 141/2000 of 16 December 1999 on orphan medicinal products.
2. The 97th USA Congress An Act to amend the Federal Food, Drug, and Cosmetic Act to facilitate the development of drugs for rare diseases and conditions, and for other purposes. Effective January 4, 1983
3. The orphan drug pipeline in Europe
4. [cited 2016 Nov 15]. Available from: www.morningstar.com
5. European Union. Treaty of Lisbon Amending the Treaty on European Union and the Treaty Establishing the European Community, 13 December 2007, 2007/C 306/01