The European Medicines Agency issued draft guidance to accelerate clinical trial authorizations during public‑health emergencies. The proposals would streamline approvals for studies relevant to the emergency and for trials addressing other life‑threatening needs, while urging sponsors to coordinate with the EMA’s Emergency Task Force to ensure efficient, well‑designed trials. The draft emphasizes prioritizing robust randomized studies over compassionate use that yields weak evidence, and it outlines flexibilities for participant transfers, adapted procedures, and alternative approaches under emergency constraints. The guidance stresses maintaining participant safety and data integrity while enabling rapid evidence generation. Stakeholders now have an opportunity to comment; implementation would change how trial sponsors plan emergency responses and could reduce fragmentation experienced during the COVID‑19 pandemic.