EMA Issues Draft Guidance for Clinical Trials During Public Health Emergencies

The European Medicines Agency (EMA) has released first draft guidance outlining how sponsors should conduct clinical trials during public health emergencies (PHEs). The document, published under the Accelerating Clinical Trials in the European Union (ACT EU) initiative, is open for public consultation until 30 April 2026.

This is the first EU guidance on PHEs aligned with the current legislative framework and updated recommendations from the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use developed after the COVID-19 pandemic.

The guidance recommends a harmonised approach to ensure clinical trials can be launched, adapted and continued efficiently during emergencies. It emphasises prioritising participation in well-designed clinical trials rather than relying on small studies or compassionate use programmes.

Sponsors are encouraged to consult EMA’s Emergency Task Force for scientific advice. For ongoing studies, the guidance suggests protocol amendments, decentralised trial procedures and reduced site visits where necessary to protect participants while maintaining reliable data generation.

09-03-2026