Use of the conditional marketing authorization pathway for oncology medicines in Europe.

Autor: Hoekman J; Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.; Innovation Studies Group, Faculty of Geosciences, Utrecht University, Utrecht, The Netherlands., Boon WP; Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.; Innovation Studies Group, Faculty of Geosciences, Utrecht University, Utrecht, The Netherlands., Bouvy JC; Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands., Ebbers HC; Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands., de Jong JP; Exon Consultancy, Amsterdam, The Netherlands., De Bruin ML; Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Jazyk: angličtina
Zdroj: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2015 Nov; Vol. 98 (5), pp. 534-41. Date of Electronic Publication: 2015 Jul 17.
DOI: 10.1002/cpt.174
Abstrakt: Conditional marketing authorization (CMA) in the European Union (EU) is an early access pathway for medicines that show promising therapeutic effects, but for which comprehensive data are not available. Using a mixed quantitative-qualitative research design, we evaluated how CMA has been used in marketing authorization of oncology medicines in the period 2006 to 2013. We show that compared to full marketing authorization, CMA is granted based on less comprehensive data. However, this is accompanied by significantly longer assessment times and less consensus among regulators about marketing authorization. Moreover, development time from first-in-human testing to marketing authorization did not differ between full marketing authorization and CMA, but was significantly longer for CMA compared to accelerated approved products in the United States (US). Results indicate that CMA is not used by companies as a prospectively planned pathway to obtain early access, but as a "rescue option" when submitted data are not strong enough to justify full marketing authorization.
(© 2015, The American Society for Clinical Pharmacology and Therapeutics.)
Databáze: MEDLINE
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