Navigating the regulatory maze for market approval is often highly complex and requires strong regulatory support and expertise. This is especially the case within academia where drug development experience can be scarcely available.
Questions relating to non-clinical development such as the choice of best animal models for pharmacokinetic or pharmacodynamic testing, as well as carcinogenicity and reproductive toxicity testing or bioassays to measure potency (biological activity), are just some of the uncertainties that academic drug developers will need to tackle.
Other questions may arise when moving to clinical phases. For instance clinical trial design, best approach to dose-finding studies, statistical analysis, choice of end points, inclusion or exclusion criteria for trial participants and many more.
Already cost-free to SMEs, The European Medicines Agency (EMA) has now waived their fee for scientific advice related to the development of orphan medicines for academic and non-profit research organisation sponsors as well.
The initiative responds to a previous call from academia to address some of the challenges encountered by non-profit organisations developing medicines when navigating the regulatory system in the European Union, confirming that providing support to academia and non-profit research organisations is essential to accelerate translation of biomedical research and increase the chances of success of orphan medicines.
The EMA’s toolbox to support development of medicines by academia can be found in a dedicated page on the EMA’s website.
EATRIS offers a regulatory support service that can help understand how to improve engagement with EMA and National Competent Authorities being complementary to EMA positioning towards academia and non-profit research organisations. Visit the EATRIS Regulatory Services page to find out more.