Introduction to EU Regulatory Affairs
Dr James Parsley
Head of CMC & Principal Consultant
Ellen Wilkinson
Senior Consultant
Introduction
In the European Union (EU) a network of approximately 50 regulatory authorities from the 30 European Economic Area (EEA) countries1, the European Commission (EC) and European Medicines Agency (EMA) form the basis of the European regulatory system and play a role in the authorisation and monitoring of medicines in this region. The continuously developing regulatory landscape and regular updates to guidance poses a particular challenge to drug developers when considering the path to marketing authorisation (MA) in the EU and which route will be most efficient and cost effective whilst still complying with regulatory guidance.
When initiating development of a new medicinal product Sponsors should first draw up a drug development strategy that considers the legal basis for approval, the product type, indication, target population, key applicable guidance and when interactions with Regulators will prove most useful. Drug development strategies will continue to evolve as more data becomes available throughout development.
In this article we provide an overview of EU regulatory affairs to help guide Developers with key decisions regarding their drug development strategy. Specifically, we explore EU product classifications, the EU legal basis for MA, considerations for designations that expedite/provide financial incentives for development and unlock early interaction with EU Regulators plus points of interaction with the EMA and National Authorities and when these are most useful during drug development. Additionally, we provide insight on considerations for clinical trial applications (CTAs) and highlight the MA Application (MAA) registration pathways available with the EMA.