The European Medicines Agency’s (EMA) Emergency Task Force (ETF) has strengthened its scientific advice process to accelerate the development of promising medicines and vaccines addressing major public health threats, including Anti Microbial Resistance (AMR).

Under the new system, developers of eligible medicines can request combined scientific advice from EMA and national clinical trial and ethics experts. This integrated approach aims to align clinical trial and marketing authorisation requirements early in the development process, enabling faster authorisation of trials and quicker access to critical medicines.

According to Marco Cavaleri, co-chair, ETF and Head, Department of Public Health Threats, EMA, the streamlined framework will offer clear guidance on trial design that meets both regulatory and ethical standards, ultimately supporting timely development and approval.

The revised process is supported by the newly established Public Health Emergencies Ethics Advisory Group under the Accelerating Clinical Trials in the EU (ACT EU) initiative, in collaboration with MedEthicsEU.