A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural Timelines.

ABSTRACT:

Background

Cancer is a serious global health problem and a major cause of death. The European Medicines Agency (EMA) has established several regulatory initiatives to expedite the development and authorization of drugs to ensure timely access of patients. In this study, we analyzed the procedural timelines of marketing authorization applications for anticancer drugs in the EU, with a specific focus to special regulatory programs, scientific advice and company size.

Methods

Anticancer drugs that received an opinion from the EMA between January 2010 and December 2019 were included in the study. Public assessment reports were used to obtain publicly available information of the drugs.

Results

We identified 96 applications for new anticancer drugs. 34 applications were gr

SUBMITTER: Garsen M 

PROVIDER: S-EPMC8238922 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature