What is PRIME? Understanding the EMA’s early support for promising medicines

Addressing unmet medical need is a key priority for the European Medicines Agency (EMA). In response to this, the agency launched the Priority Medicines scheme in 2016. Its core aim, and its appeal for developers, is to offer early and enhanced regulatory support to accelerate the development of potentially transformative medicines. Key features of PRIME […]

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 […]