The initiative will focus on activities that aim to facilitate large and multinational clinical trials in the European Union (EU) to promptly tackle public health emergencies.
The COVID-19 pandemic and the MPX emergency brought to the fore structural challenges and barriers that impede the fast set up and start of adequately sized, multinational clinical trials. Lessons learned have raised the need to define and implement optimised processes.
Different aspects of the process of clinical trial approval will be tackled including increasing collaboration across national competent authorities and ethics committees, and the role of the European Medicines Agency's Emergency Task Force in fostering alignment and discussion across Member States.
Several aspects related to exceptional flexibilities which are needed for the rapid approval of clinical trials will also be addressed, based on the experience gained in the pandemic and previous emergencies.
