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 development, and then wait six months before engaging again. That’s a missed opportunity. The rapporteur is there to support your programme throughout its development, not just at major milestones.
For example, as you review your meeting minutes, new questions may emerge, or previously unforeseen issues might arise. You can (and should) reach out to your rapporteur at any time. This ongoing dialogue can be instrumental in addressing regulatory uncertainties before they become roadblocks.
PRIME: More than a milestone
PRIME designation is hard-won, as we explored in the previous blog. Sponsors clearly see the value of early scientific advice, but many fail to make full use of the ongoing support it offers. This can leave sponsors ill-prepared for the marketing authorisation application (MAA) or for seeking conditional marketing or accelerated assessment pathways.
The result? Missed conversations, missed insights, and missed opportunities to strengthen development strategy and regulatory readiness.
Investor attention – but for the right reasons
PRIME is often pursued to demonstrate progress to investors. It can mark a major milestone, signalling regulatory confidence and a potential pathway to accelerated assessment.
However, treating PRIME as just another item on an investor-facing checklist is short-sighted. While PRIME may increase the likelihood of accelerated assessment, it’s not guaranteed, and focusing solely on that goal means you’re overlooking its true value.
When used strategically, PRIME can help streamline product development, improve data quality and shape a more compelling value story. This ultimately serves both regulatory success and investor confidence.
The Patient-centred purpose of PRIME
To truly realise the benefits of PRIME, sponsors should keep in mind its core purpose: facilitating faster access to innovative treatments for patients with unmet medical needs. It’s not about gaining EMA approval; it’s about getting effective medicines to people who need them across Europe.
Robust evidence developed through PRIME can also support joint clinical assessment (JCA) under the EU’s Health Technology Assessment Regulation (HTAR) and strengthen discussions with national payers. By using PRIME to align early with regulators and stakeholders, including patients, sponsors are better places for downstream success.
Maximise what PRIME offers
PRIME provides a rich offering of meetings and feedback opportunities, and sponsors should take full advantage. The rapporteur and scientific coordinator can act as trusted guides throughout your development journey.
Working with an experienced regulatory consultant who has navigated the PRIME process can also help you interpret advice and use the designation to its fullest potential.
Whether it is a milestone with your existing investors or a way to attract new investors to get your studies off the ground or start the next phase of your clinical trial, PRIME is seen as a huge advantage.