The European Medicines Agency (EMA) will waive all fees for the provision of scientific advice to applicants from academia developing medicines for the treatment of rare diseases.
The academic sector plays an essential role in the development of innovative medicines, which can also benefit patients with rare diseases. Still, its orientation in the regulatory process and fees for EMA expert advice (e.g.protocol assistance) are important obstacles. Rare diseases are diseases that are life-threatening or chronically debilitating diseases and affect more than five out of 10,000 people in the EU.
In the light of these findings and support of EMA's cooperation with academia as set out in the "EMA Regulatory Science to 2025" and the "EMA action plan for small and medium-sized enterprises (SMEs)", EMA has decided to include academia in the list of organizations that are entitled to free professional advice from 19 June 2020.
Eligible applicants will be public or private higher education institutions awarding academic degrees; public or private non-profit research organizations whose main mission is research and international European interest organizations.
These entities should not be funded or managed by private for-profit pharmaceutical companies.
For more information, see here.
You can find more about EMA's expert advice here.