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.
About scientific advice
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.
About EMA’s Emergency Task Force (ETF)
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.
ACT EU work on clinical trials in public health emergencies
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.