To further encourage the development of treatments for rare diseases, the European Medicines Agency (EMA) will waive all fees for scientific advice for academia developing orphan medicines.
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.
Early interaction with EU regulators is important for academia to understand the regulatory requirements and allow the generation of robust evidence needed to establish the medicines’ benefits and risks. This helps them to navigate the regulatory process and ultimately to translate their discoveries into authorised, patient-focused medicines.
However, feedback from academia showed that fees for protocol assistance (scientific advice for orphan medicines) represent a hurdle to engage with EMA.
In light of these findings and the actions foreseen in the Agency’s framework of collaboration with academia, the EMA decided to include academia in the list of organisations eligible for free protocol assistance as of 19 June 2020.
For more information see the EMA website.