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More information12th March 2026
Summary:
The European Medicines Agency (EMA) has published new guidance to support the conduct of clinical trials during public health emergencies across the European Union. The guidance sets out recommendations for sponsors, investigators and regulators on how to maintain the integrity, safety and quality of clinical trials when emergencies such as pandemics or major health crises disrupt normal research activities. It covers areas including trial management, participant safety, data collection and regulatory coordination, helping ensure that clinical research can continue while protecting participants and maintaining robust evidence generation. The guidance aims to support preparedness and consistent approaches across the EU when urgent public health situations arise.