Early-Phase Development Strategies For Navigating Regulatory Complexity In The EU

An effective regulatory strategy is essential for any clinical development program. While every region presents its own complexities, sponsors currently find regulatory compliance particularly challenging in the European Union (EU). New regulations—Clinical Trial Regulation 536/2014 (EU-CTR), Medical Devices Regulation 2017/745 (EU-MDR), and In Vitro Diagnostics Regulation 2017/746 (EU-IVDR)—have introduced new processes, leading to delays in trial initiation. This has led some companies, especially non-European biotechs, to consider shifting early-phase development out of the EU.

We understand the pressures sponsors face. While conducting trials in regions like North America, the U.K., or Asia-Pacific may simplify study launches in the short term, it's important to consider the long-term implications of moving away from the EU. Europe remains one of the world’s largest pharmaceutical markets, offering well-established sites and experienced teams that can streamline patient recruitment and operations, mitigating regulatory delays. Additionally, the European Medicines Agency (EMA) application process provides access to 30 countries, offering sponsors significant flexibility in site selection.

We encourage sponsors to leverage these advantages while we help them develop strategies to expedite early-phase development. Since most therapies will eventually require EMA approval, sponsors who adapt to EU requirements now will be better positioned for future success.