EMA Emergency Task Force (ETF) - Update of Scientific Advice submission forms

Per Regulation (EU) No 2022/123, the EMA Emergency Task Force (ETF) is mandated to provide scientific advice (SA) on the development of medicinal products targeting declared or potential public health emergencies. Currently COVID-19 and Monkeypox are declared public health emergencies of international concern. The pathogens with potential to cause a public health emergency are for example Zika virus, Ebola virus, Chikungunya virus, other Coronaviruses or Pandemic influenza viruses. In addition, ETF together with the Clinical Trial Coordination Group (CTCG) and the MSs facilitate the approval and conduct of clinical trials for medicinal products targeting public health emergencies by providing scientific advice on trial protocols and support on aspects related to clinical trial authorisation.

The SA submission forms, namely the “Administrative Information” section for the initial and follow up SA applications, have been updated with additional questions to distinguish between the standard SAs and the SAs related to declared or potential public health emergencies (refer to section 4.2 in the IRIS guide for applicants).