European regulatory use and impact of subgroup evaluation in marketing authorisation applications
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Publication date
2017-12
Authors
Tanniou, Julien
Teerenstra, Steven
Hassan, Sagal
Elferink, Andre
van der Tweel, I.
Gispen-de Wied, Christine
Roes, Kit C B
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Document Type
Article
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Abstract
Marketing authorisation application dossiers relating to medicinal products containing new active substances and evaluated by the European Medicines Agency (EMA) over the period 2012-2015 were examined. Major objections and other concerns relating to efficacy and safety of the day 80 assessment reports were reviewed. Overall, approved products have more subgroup concerns than nonapproved products, which seems to be a consistent pattern. Subgroup analyses are mainly assessed to have the insurance that subgroups of patients that might lack a positive benefit: risk ratio will not be wrongly included in the approved treatment indication.
Keywords
Pharmacology, Drug Discovery, Journal Article
Citation
Tanniou, J, Teerenstra, S, Hassan, S, Elferink, A, van der Tweel, I, Gispen-de Wied, C & Roes, K C B 2017, 'European regulatory use and impact of subgroup evaluation in marketing authorisation applications', Drug Discovery Today, vol. 22, no. 12, pp. 1760-1764. https://doi.org/10.1016/j.drudis.2017.09.012