Expert comment: EMA strengthens Scientific Advice process for medicines addressing public health threats

The European Medicines Agency’s (EMA) Emergency Task Force (ETF) is strengthening its support for the development of promising medicines and vaccines against public health threats by introducing a new procedure for a combined scientific advice (SA) with input from the EMA, as well as clinical trial and ethics experts at national level.

The overall goal is to ensure alignment between the regulatory approval requirements and national or ethics perspectives on clinical trial applications (CTA). This shall be achieved by involving the ETF, the Clinical Trial Coordination Group, Member States, National Competent Authorities and a newly created group of ethics experts, the Public Health Emergency Ethics Advisory Group, in the scientific advice procedure. The procedure is available for products which fall within the scope of the ETF’s activities, including medicines for antimicrobial resistance and other health threats that have the potential to cause public health emergencies.

The new guidance document ‘Guidance for applicants: the ETF scientific advice that facilitates clinical trial authorisations (SA-CTA)’ outlines how developers of such medicines can request the combined advice. Applicants should follow the standard EMA SA procedure, including existing timelines, submission deadlines and applicable fees. The application dossier should include the usual SA briefing document along with either a mature clinical trial protocol or a draft protocol synopsis and details on the Member States Concerned (MSCs) and the proposed Reporting Member States (RMS) participating in the CTA.

Marco Cavaleri, ETF co-chair and Head of EMA’s Department of Public Health Threats, commented that “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.” By aligning the requirements for clinical trials and marketing authorisation applications at an early stage, the new process is expected to accelerate the approval of both clinical trials and the medicines/vaccines developed to address public health threats.