EMA’s Emergency Task Force (ETF) is improving its approach to scientific advice for the most promising medicines and vaccines under development for public health threats.
Under the new process, developers of medicines falling within the scope of the ETF’s activities, including medicines for antimicrobial resistance (AMR) and other health threats that have the potential to cause public health emergencies, can apply for combined scientific advice from EMA, as well as clinical trial and ethics experts at national level. As a result, requirements for clinical trials and marketing authorisation of medicines and vaccines for public health threats will be aligned at an early stage, which should lead to more rapid authorisation of clinical trials and of these medicines.
“With this new approach, developers will receive clear input on the design of clinical trials to allow generation of adequate evidence, and how these trials should be conducted according to both regulatory and ethical considerations. The new system enables input on science and ethics at the same time, with the overall aim of speeding up medicines development and approval.”
The approach will be crucial to enhance the rapid development and approval of medicines ahead of and during public health emergencies. The overall goal is to ensure alignment between the regulatory approval requirements and national or ethics perspective on clinical trial applications.
The involvement of ethics experts in this process is made possible through a newly established Public Health Emergencies Ethics Advisory Group under the Accelerating Clinical Trials in the EU (ACT EU) initiative in collaboration with MedEthicsEU.
Scientific advice is an important step in the development of a medicine, providing guidance on the best methods and study designs to generate robust evidence of a medicine's benefits and risks. This advice helps to ensure that trials are well-designed, efficient and generate meaningful data for regulatory review.
The ETF is an advisory and support body that handles regulatory activities in preparation for and during public health emergencies, including pandemics. The task force provides scientific advice and regulatory guidance to support the development of medicines and vaccines for preparedness and /or use during outbreaks and emergencies. The framework covers products addressing pathogens and threats identified in the ETF’s remit. AMR was added in March 2025 as a priority area. ETF scientific advice now covers selected areas related to AMR, such as bacterial vaccines, tuberculosis and treatments impacting infections due to multi-drug-resistant pathogens.
Several aspects concerning the authorisation of clinical trials during emergencies are being addressed under ACT EU, including regulatory and technical flexibilities to facilitate trial assessment and authorisation, and a preliminary analysis of the benefits of a European central ethics committee during public health emergencies.