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
A defining feature of PRIME is early engagement, giving sponsors direct access to EMA regulators and more timely scientific advice.
Once a product receives PRIME designation, the sponsor is assigned a dedicated rapporteur who acts as their central EMA contact throughout development. This is unusual in the EMA context, where a single point of contact is not typically provided. However, this one-on-one guidance can be a major advantage, allowing for tailored scientific advice and streamlined regulatory interaction. When a sponsor requires specific input, the rapporteur can direct them to the appropriate EMA experts and procedures.
In addition, PRIME designation opens the door to accelerated assessment at the marketing authorisation stage. This can reduce the evaluation timeline from 210 to 150 days, helping promising therapies reach patients sooner.
Who is eligible and how to apply
PRIME is available to sponsors developing medicines that target unmet medical needs, either by offering a treatment where none exists or by demonstrating a significant advantage over existing options.
To apply, a sponsor must present data showing improved clinical outcomes, such as delaying disease onset, shortening duration, or improving morbidity or mortality.
Small and medium-sized enterprises (SMEs) and academic developers can apply early in development, based on non-clinical proof of principle data, which is typically evidence from animal models and early safety studies. If granted early-entry PRIME status, these applicants attend an introductory meeting with the EMA, receiving regulatory guidance tailored to early-stage development and advice on generating proof-of-concept data.
Larger companies may also apply, but they are generally required to submit clinical proof-of-concept data. This makes PRIME less accessible in early stages for large sponsors; however, it can still be a valuable route for those developing highly innovative therapies that could benefit from early EMA engagement.
Given the significant advantages PRIME status offers, it is essential that applications are carefully prepared. Engaging an experienced regulatory consultant with a track record in PRIME submissions can help sponsors maximise the scheme’s benefits.
Early interaction is a key feature of PRIME, giving sponsors an opportunity to interact directly with the regulators, as well as faster access to scientific advice.