Early-phase development strategies for navigating regulatory complexity in the EU

Insightful regulatory strategy is foundational to any clinical development program. And while we encounter complexities in every region, sponsors say the work of interpreting and addressing regulatory guidance is particularly challenging right now in the European Union (EU). Three recent regulations — Clinical Trial Regulation 536/2014 (EU-CTR), Medical Devices Regulation 2017/745 (EU-MDR), and In Vitro Diagnostics Regulation 2017/746 (EU-IVDR) — require sponsors to follow new processes and have resulted in delays in initiating clinical trials. This has prompted some companies, particularly non-European biotechs, to consider moving early-phase development out of the region.

We’re sensitive to the pressures that sponsors face. Conducting trials in North America, the U.K., or the Asia-Pacific region could make study launch simpler in the short term. But Europe is one of the world’s largest pharmaceutical markets, so we urge sponsors to consider long-term impacts of shifting away from the EU.

The EU offers well established sites and experienced teams that can streamline patient recruitment and operations to help offset regulatory delays. And through its application process, the European Medicines Agency (EMA) offers access to 30 countries, which gives sponsors great freedom in site selection. We’re encouraging sponsors to maximize these advantages as we also help them develop strategies for expediting early-phase development.

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