The European Medicines Agency (EMA) works to achieve scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union (EU).
The academic sector is an important source of novel methodologies and innovative medicines with a possible function in the treatment of rare diseases. A close relation with EU regulators is necessary for academia to assess the requirements needed for the translation of breakthroughs into the clinical practice. However, feedback from academia has indicated that fees for protocol assistance (scientific advice for orphan medicines) may represent hamper the engagement with EMA.
Aiming to boost the development of innovative treatments for rare diseases EMA has recently waived all fees for scientific advice for academic researchers focused on orphan medicines. Eligible applicants are specified in their website.