With a large population spread across 27 Member States, the European Union (EU) constitutes a major market for pharmaceutical and biotechnology companies. Obtaining marketing authorization (MA) in the EU can be a critical step in securing a commercial foothold for a new medicinal product or in providing vital momentum to a sponsoring company’s market expansion plans. Yet for some companies, the EU regulatory landscape may present a bewildering array of customs, regulations, and procedures. Understanding how to navigate it is key to securing approval in the market.
In this guide, we outline the different types of EU MA procedures, the differences and similarities between the U.S. and EU regulatory processes, and tips and best practices for developing and submitting a successful EU MA application.