EU marketing authorization review of orphan and non-orphan drugs does not differ

Autor:	Michelle Putzeist, C.C. Gispen-De Wied, J. Llinares, Arno W. Hoes, Hubert G. M. Leufkens, Aukje K. Mantel-Teeuwisse
Rok vydání:	2013
Předmět:	Marketing Pharmacology Orphan Drug Production business.industry MEDLINE Accounting Marketing authorization Orphan drug Pharmaceutical Preparations Drug Discovery Agency (sociology) Animals Humans European Union business Drug Approval
Zdroj:	Drug Discovery Today. 18:1001-1006
ISSN:	1359-6446
Popis:	Marketing authorization application dossiers of 17 orphan drugs (ODs) and 51 non-ODs evaluated by the European Medicines Agency (EMA) in the period 2009-2010 were compared. We aimed to identify whether any differences existed between ODs and non-ODs in number and type of deficits brought forward during the EMA review, regarding the clinical development plan, clinical outcome and medical need and studied whether these deficits were similarly associated with marketing approval in the EU. In 71% of the ODs dossiers and 65% of the non-ODs dossiers marketing approval was granted. Differences in deficits were found, but similarities in the way ODs and non-ODs were reviewed and marketing approval decisions were taken, underline that regulatory standards are equally high.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8e16de12eb5b60b220e92535583d0da7 https://doi.org/10.1016/j.drudis.2013.06.012 Zobrazit plný text záznamu Full Text from ScienceDirect