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https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm2005643.htm
" (1983). Accessed 6 March 2018.
2. EC: Regulation No 141/2000 of the European Parliament and of the Council on Orphan Medical Products.
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2000_141_cons-2009-07/reg_2000_141_cons-2009-07_en.pdf
(2000). Accessed 6 March 2018.
3. PMDA: The Article 77–2 of the Pharmaceutical Affairs Law.
https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/dl/05.pdf
(1985). Accessed 6 March 2018.
4. FDA: Orphan Drug Designations and Approvals.
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/
(2018). Accessed 6 March 2018.
5. EMA: European public assessment reports.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124
(2016). Accessed 6 March 2018.