Dr Ina Gerstberger and Dr Mirjam Liebmann | Gowling WLG

reference

Gerstberger I, Liebmann M. Regulation of orphan drugs within the EU. European Pharmaceutical Review. 2017;3:14-16

12 July 2017 | By Dr Ina Gerstberger and Dr Mirjam Liebmann | Gowling WLG

References Cf. Straeter/Burgardt/Bickmann, Arzneimittel für seltene Leiden – Situation in der Europäischen Union, A&R 2014, 195 with further references. Recital 2 of Regulation (EC) No 141/2000. See also Hiltl, Orphan Drugs – Zwischenbilanz und Konfliktfelder, PharmR 2001, 308. Regulation (EC) No 141/2000 of the European Parliament and of the Council…

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Regulation of orphan drugs within the EU

29 June 2017 | By Dr Ina Gerstberger and Dr Mirjam Liebmann | Gowling WLG

Simply put, an orphan drug is indicated for the treatment of a very rare disease. Such diseases are often due to genetic defects and therefore children and newborns are affected to a great extent1.