As part of efforts to increase academia’s engagement and trust in the regulatory system, the European Medicines Agency (EMA) on Monday announced a new formal framework to better structure interactions between academia and the agency.
The framework and action plan for the next three years were adopted by EMA’s Management Board in March and feature new ways to evaluate academic entities interested in regulatory activities, build on the available expertise to keep pace with scientific advances, identify opportunities to promote research, and monitor progress and output of new cooperation.
"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," EMA’s Executive Director Guido Rasi said in a statement. "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."
Background
With academic research and other public-private partnerships helping to develop about 17% of the 94 products approved between 2010 and 2012, and the European Council and the current EU Research and Innovation Programme Horizon 2020 emphasizing the need to accelerate the translation of biomedical and clinical research results into new medicines, EMA is looking to highlight specific areas where dialogue is either required or highly recommended.
Currently, like in the US, academia provides European regulators with thousands of experts to ensure new treatments are evaluated and monitored.
In February 2016, EMA said it would like to build on its work with academia via this new framework and the regulator will look to ensure it has the capability to regulate novel products and to strengthen its capability to adequately assess and monitor them.
Objectives
In addition to building trust and engagement, the framework’s overall objectives are to:
- foster the translation of academic research into novel methodologies and medicines which meet regulatory standards and address needs of public and animal health
- ensure that the best scientific expertise and academic research are available to support effective evidence generation, regulatory advice and guidance, as well as decision-making in regulatory processes
- work with academia to develop regulatory science that embraces scientific progress in medicines development without compromising patient safety, such as via the use of novel endpoints or novel methodologies
EMA also published on Monday a new website for academia with links likely to be of interest, and a section describing the way EMA interacts with academia, with more detail on the collaboration framework and action plan and useful resources.
Giovanni Migliaccio, scientific director of European infrastructure for translational medicine (EATRIS-ERIC), said in a statement: "We are very excited about the new framework, as it marks an important step in Europe’s continuing efforts to boost innovation at the leading edge of science. EATRIS-ERIC and our fellow European Strategy Forum on Research Infrastructures (ESFRI) look forward to contributing to the actions arising from this initiative."
An annual report on the implementation of the framework will be presented to EMA’s management board in the third or fourth quarter of 2018.
EMA