EMA Improves Scientific Advice for Medicines Addressing Public Health Threats —including Antimicrobial Resistance

19th November 2025

EMA Improves Scientific Advice for Medicines Addressing Public Health Threats —including Antimicrobial Resistance

Summary: EMA has updated its scientific advice framework to more explicitly cover medicines targeting declared or potential public-health emergencies, including antimicrobial resistance (AMR). Developers can now request early-stage support through the EMA’s Scientific Advice & Protocol Assistance service, with a newly added section focused on public health threats. This enhancement enables better interaction between developers and the regulatory network, including the Emergency Task Force (ETF) when needed, helping to align development plans for treatments against high-priority threats. The aim is to encourage innovation, improve regulatory predictability, and accelerate access to medicines for serious unmet needs.

Link: Improved Scientific Advice for Public Health Threats, including AMR – EMA

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