EMA offers free orphan drug advising to academia

Regulatory NewsRegulatory News | 23 June 2020 |  By 

Academic organizations working on drug development for rare diseases will now be eligible for waiver of fees for scientific advice from the European Medicines Agency (EMA), according to an updated Executive Decision issued by the agency.

“The academic sector plays an important role in the development of innovative medicines. Their scientific research is often at the source of novel methodologies and innovative medicines with the potential to benefit patients with rare diseases,” said EMA in announcing the news.

The updated policy, said EMA, recognizes that development of therapies for rare diseases in academia benefits from early discussions with regulators in the European Union. Early interaction and a thorough understanding of regulatory requirements allows study designs to be shaped with an eye to a robust trial process. The fees that had been asked of academia for assistance with developing protocols, however, had presented a hurdle in their efforts to achieve this early engagement with EMA.

Those eligible for waiver of advice fees include both public and private institutions of higher education that award academic degrees, public and private nonprofit organizations whose primary mission is research, and international European interest organizations. To be eligible, entities cannot have a final agreement with a pharmaceutical company regarding sponsorship or participation in the research project for which the exemption is sought. Also, the entities must be independent of for-profit pharmaceutical organizations.

This free access to advice early in the drug development process is part of EMA's overall framework for collaboration with academia, formulated in 2017. The new fee exemption for academic also fits with EMA’s regulatory science strategy to 2025 and its action plan for small and medium-sized enterprises, said the agency.

The expanded eligibility is detailed in an updated EMA document detailing fee reduction eligibility for designated orphan medicinal products; the document clarifies that the a sponsor of an orphan medicinal product may claim a total or partial fee reduction once orphan designation has been granted by the European Commission. Academic sector applicants are eligible for 100% reduction of fees once they have submitted their application for a service; no separate requests or forms are required.

Before waivers, fees imposed by EMA for initial requests for scientific advice range from 44,400 Euro to 89,000 Euro; fees for followup scientific advice range from 22,400 Euro to 44,400 Euro.

The expanded eligibility for free protocol assistance is effective as of 19 June.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy