As a science-driven organization, the EMA has developed a framework to formalize, 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.
“Academia play an important role in helping the EU medicines regulatory network keep abreast of the opportunities and challenges brought by science, be it in the context of the development, assessment or safety monitoring of medicines, said the EMA’s Executive Director Guido Rasi. “The framework will allow us to integrate cutting-edge scientific knowledge more tightly into our activities. It will also help academic start-ups benefit from advice from the EU regulatory network to translate their discoveries into patient-focused medicines.”
The framework’s overall objectives are:
raising awareness of the mandate and work of the European medicines regulatory network to increase academia’s trust 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.
The framework builds on EMA’s experience in interacting with stakeholder associations representing patients and consumers, healthcare professionals and the pharmaceutical industry, which is based on the fundamental principles of transparency, independence and integrity, accountability, and broad representation.
Along with the framework, EMA has developed an action plan which includes, among other activities, initiatives for mutual education and training, staff exchange programs to promote mutual learning, a strategic research agenda for regulatory science and the creation of an EMA entry point for academia to receive information on available support within the EU Regulatory Network.
