Posted by Michael Wonder on 23 Jun 2020
Academia developing medicines for rare diseases to receive free EMA scientific advice
23 June 2020 - To further encourage the development of treatments for rare diseases, 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 a 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.
