Why a proper understanding of PRIME is key to a successful regulatory journey

The tailored scientific advice and regulatory guidance offered through EMA’s PRIME scheme are a major draw for sponsors. While it is often assumed that PRIME is focussed on rare diseases, that is not necessarily the case. Sponsors developing products identified by EMA as public health priorities may be eligible. These include treatments for antimicrobial resistance […]

Not just a tick-the-box exercise: Getting the most out of PRIME designation

The European Medicines Agency’s (EMA) PRIME designation offers significant benefits to sponsors. Perhaps most valuable of these is the opportunity to receive tailored scientific advice and regulatory support from a dedicated rapporteur and scientific coordinator. Yet, in our experience, many companies underutilise this service. Too often, they attend an initial meeting, note the outcomes, begin […]