The European Medicine Agency’s (EMA) Emergency Task Force (ETF) is offering medicine developers the chance to apply for scientific advice for antimicrobial resistance medicines and other health threats that can become a major issue during public health emergencies.
The ETF offers scientific advice and guidance to support the acceleration and approval of medicines during times of emergencies. The advice includes guidance for both clinical and non-clinical processes, clinical trial applications (CTA) and pharmacovigilance.
Supporting activities related to antimicrobial resistance was included in the ETF 3-year Work Plan published in February 2025 and was added to the EMA ETF agenda as a priority area in March 2025.
The ETF Co-chair and Head of the EMA’s Department of Public Health Threats, Marco Cavaleri, said, ‘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 EMA defines scientific advice as ‘Guidance on the best methods and study designs to generate robust evidence of a medicine’s benefits and risks’. This helps to ensure clinical trials are accurate and efficient, leading to the development of safer and more effective medicinal products, while also often increasing market acceleration.
Guidance for professionals who wish to apply for scientific advice is available here.
