Learning from the EMA experience: common CMC deficiencies in marketing authorisation applications over the past decade

Abstract

Here, we present an analysis of major objections (MOs) raised on quality aspects during review of marketing authorisation applications (MAAs) for new medicines via the centralised procedure in the European Union (EU). The review covers a 10-year period by analysing data from 2013, 2018, and 2023. We identify common deficiencies, which should help developers prepare dossiers aligned with EU and global standards and avoid delays to approval of medicines, thereby improving patient access to medicines. The most common deficiencies are correlated with specific product types, recent public health crises, new legal frameworks, and the publication or revision of guidance.