Enhanced expert advice for developers of AMR medicines

Companies developing medicines or vaccines targeting antimicrobial resistance (AMR) can now avail of improved scientific advice from the European Medicines Agency (EMA). The new approach brings together expertise from clinical trial and ethics committees to accelerate the development of products used during emergencies. The move reflects the seriousness with which regulators view the growing AMR crisis.

The EMA Emergency Task Force will offer combined scientific advice from the Amsterdam-based EU drug watchdog as well as clinical trial and ethics expertise at national level. As a result, it says 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,’ said Marco Cavaleri, co-chair of the Task Force and Head of the EMA’s Department of Public Health Threats. ‘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 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.