EMA Publishes Framework and Action Plan for Closer Interaction

The European Medicines Agency (EMA) has developed a framework to formalise, structure and further develop interactions with the academic community in the context of the European medicines regulatory network.

The framework and an action plan for the next three-years were adopted by EMA’s Management Board at its March 2017 meeting.

The framework’s overall objectives are:

  • raising awareness of the mandate and work of the European medicines regulatory network to increase academia’strust in and engagement with the regulatory system;
  • fostering the translation of academic research into novel methodologies and medicines which meet regulatory standards and address needs of public and animal health;
  • ensuring that the best scientific expertise and academic research are available on time to support effective evidence generation, regulatory advice and guidance, as well as decision-making in regulatory processes;
  • working with academia to develop regulatory science that embraces scientific progress in medicines development without compromising patient safety, such as for example, the use of novel endpoints or novel methodologies.