The European Medicines Agency (EMA) will work to encourage development of medicines for rare diseases by waiving the fees it charges for scientific advice for academics working on such treatments.
EMA acknowledges the crucial role played by academia in the early stages of treatment development, often spearheading new approaches later relied on by the industry. However, academic groups often do not have ready access to finance, meaning the fees for services such as EMA’s protocol assistance (scientific advice for orphan medicines) can be prohibitive.
“In light of these findings and the actions foreseen in the Agency’s framework of collaboration with academia, the Regulatory Science Strategy to 2025 and the EMA SME action plan, EMA decided to include academia in the list of organisations eligible for free protocol assistance as of 19 June 2020.
“Eligible applicants will include public or private higher education establishments awarding academic degrees, public or private non-profit research organisations whose primary mission is to pursue research, and international European interest organisations.”
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