Europe – EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines

The European Medicines Agency (EMA) together with the responsible scientific committees and their working parties, and in collaboration with the European Commission, operates rapid procedures to support the development and evaluation of treatments and vaccines for COVID-19. The EMA emerging health threats plan foresees that detailed procedures are set-up to adapt different types of review activities to the needs of the health threat/crisis situation. Whilst respecting the regulatory requirements and established review principles (e.g. independence of experts), these procedures aim, within timelines that are appropriate for the public health emergency situation, to provide most efficient management of product-review activities leading to scientifically sound and robust outcomes…