EMA launches streamlined process to fast-track critical medicines, vaccines

The move is expected to be crucial during health crises

European Medicines Agency (EMA) is overhauling its approach to advising developers of medicines and vaccines for public health threats. This aims at speeding up approvals for pharmaceuticals industry and get vital treatments to patients faster. 

Under a new system, developers of high-priority medicines—including those targeting antimicrobial resistance (AMR) and potential public health emergencies—can now receive combined scientific advice from EMA and clinical trial and ethics experts at the national level. 

This early-stage alignment ensures that requirements for clinical trials and marketing authorisation are coordinated, reducing delays in bringing promising treatments to market. 

"With this new approach, developers will receive clear input on the design of clinical trials to generate adequate evidence, and guidance on how these trials should be conducted according to both regulatory and ethical standards," said Marco Cavaleri, ETF co-chair and Head of EMA’s Department of Public Health Threats. 

"This system enables input on science and ethics at the same time, with the overall aim of speeding up medicines development and approval." 

The move is expected to be crucial during health crises, ensuring that life-saving treatments are ready ahead of and during public health emergencies. By integrating regulatory and ethical perspectives early, EMA hopes to avoid the delays that have historically slowed clinical trials and marketing authorisations. 

A key element of the initiative is the involvement of ethics experts through the newly established Public Health Emergencies Ethics Advisory Group, created under the Accelerating Clinical Trials in the EU (ACT EU) initiative in collaboration with MedEthicsEU. 

This group will provide guidance on ethical considerations in trial design, further strengthening the alignment between scientific and ethical standards. 

EMA’s revamped process reflects growing recognition of the need for a rapid, coordinated response to emerging public health threats. By streamlining advice and approval pathways, the agency is positioning Europe to respond faster to diseases that could have major societal impacts.