A detailed analysis of expedited regulatory review time of marketing authorization applications for new anticancer drugs in the US and EU.

ABSTRACT: The aim of this study was to assess the effect of expedited regulatory approval programs used by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), type of product (small molecule or biotechnology-derived product) and consulting scientific advisory committees on the regulatory review time of the marketing authorization applications (MAAs) for new anticancer drugs. A dataset composed of 76 new anticancer drugs was constructed. The date of submission of the MAAs in the United States and the European Union were comparable. The typical review time of MAAs was 136 days shorter in the United States (201 days [median]) than in the European Union (337 days [median]). The type of product did not have a high impact on the review time. The review time of the MAAs for d

SUBMITTER: da Costa Goncalves F 

PROVIDER: S-EPMC9372420 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature