Introduction
The European Medicines Agency's (EMA) Priority Medicines (PRIME) scheme offers early regulatory support to accelerate the development of innovative medicines addressing unmet medical needs. In 2023, the EMA introduced several new features to the scheme based on the findings of its five-year review of PRIME in practice. This article explores the PRIME scheme, its benefits, and the key findings of the EMA's 5-year PRIME review.
Highlights
- An overview of the PRIME scheme
- What Are the Key Changes to the EMA’s Priority Medicines Scheme?
- Key findings from the EMA’s 5-year PRIME review
- How Does the EMA’s PRIME Scheme Benefit Medicine Developers?
- Who Is Eligible to Apply for the PRIME Scheme?
- PRIME and the Innovative Licencing and Access Pathway (ILAP)
The PRIME scheme
The EMA’s PRIME scheme was launched in 2016 to provide early and proactive support to developers of promising new medicines aiming to address unmet medical needs in a two-pronged approach:1
- Offering early interaction and scientific advice to ensure the most robust data is collected, using the most appropriate clinical trial methods throughout development.
- Guiding medicine developers with the best evidence generation methods means that medicinal products under the PRIME scheme could lead to a high-quality MAA dossier, allowing an accelerated assessment.
Who Is Eligible to Apply for the PRIME Scheme?
The PRIME scheme is open to sponsors of new medicines under development addressing conditions with unmet medical needs. To qualify, applicants must demonstrate their medicine’s potential to: 1
- Significantly address an unmet medical need, for instance by introducing new therapies or enhancing existing ones.
- Show meaningful improvement of clinical outcomes, such as improvement of morbidity or mortality or impact on prevention, onset and duration of a disease.
Small and medium-sized enterprises (SMEs) and academic researchers can apply for early entry PRIME status with early-stage data, provided they show proof of principle through compelling non-clinical data in a relevant model and initial human studies show adequate exposure and tolerability.
The scheme does not support products in advanced development, in the pre-submission phase, or those seeking new indications for authorised medicines in the EU.
How does the EMA’s PRIME Scheme benefit medicine developers?
Developers participating in the PRIME scheme gain:1
What are the key changes to the EMA’s Priority Medicines Scheme?
In March 2023, EMA introduced several updates to the PRIME scheme following a review of its first five years in practice. These updates aim to strengthen support for developers and include:2
- Product Development Roadmaps and Trackers: Continuous dialogue between developers and regulators is now facilitated through roadmaps and trackers, enabling better monitoring of progress and identifying important areas for discussion.
- Expedited Scientific Advice: PRIME developments facing specific challenges, which have been discussed in previous advice procedures can access fast-tracked scientific advice during a 12-month pilot period running until March 2024, ensuring timely resolutions.
- Submission Readiness Meeting: Scheduled approximately one year before the marketing authorisation application (MAA), this meeting aims to assess development progress, address regulatory challenges, and review post-marketing evidence-generation plans.
Key findings from the EMA’s 5-year PRIME review
Overall findings revealed that the greatest benefit of the PRIME scheme is its improvement in evaluation time during the MAA procedure. Findings also pointed to a pronounced benefit for small and medium-sized enterprises (SMEs) and developers of Advanced Therapy Medicinal Products (ATMPs) and orphan medicines .3
The EMA’s review identified ways to enhance the PRIME scheme in the future. These recommendations aim to improve support for promising medicines targeting unmet medical needs and optimise the development and approval process.
1. PRIME Eligibility: Scope and Timing
To ensure PRIME is granted to the most promising products at the best time point during their development, the following were proposed for consideration:3
2. Flexible Scientific Advice Provision
To allow more flexibility in the provision of scientific advice for PRIME products, the EMA proposed to:3
- Work with ongoing initiatives to strengthen the scientific advice process.
- Develop guidance explaining the rules of engaging with the agency and rapporteurs, and under which circumstances increased flexibility in scientific advice procedures may be considered.
- Consider the possibility of regular involvement of rapporteurs in scientific advice.
3. Knowledge Building Through Development Trackers
EMA recommended the development of product development trackers to:3
- Monitor the progress of development areas highlighted in scientific advice procedures.
- Record all rapporteur and EMA engagement activities and the outcome of discussions and completed studies.
- Allow the EMA to identify programmes that have stalled and focus resources on other programmes that would benefit from input.
- Act as a guide to discussions at meetings with the EMA throughout development.
4. Strengthening Submission Readiness
To help products on the PRIME scheme, which are also eligibility for accelerated assessment, maintain an accelerated assessment timeline (150 days instead of 210 days), the EMA proposed to enhance engagement between the kick-off meeting and MAA submission with a submission readiness meeting.3
The submission readiness meeting would aim to review the areas of development highlighted at the kick-off meeting and discussed at scientific advice to advise the medicine developer on areas of concern and MAA submission planning.3
What are the approval rates of medicines in the PRIME scheme?
As of April 2025 , the EMA had received 536 applications for PRIME designation. Of the requests, only 26% were granted eligibility. The majority of applicants were SMEs (54.6%); 62 applications were deemed eligible for PRIME, while 231 were denied. Oncology products constituted the majority of applications (27.4%) and the success rate was similarly low (39/147=26.5%). In return for the advantages offered by the scheme outlined above, the EMA has set the bar for eligibility very high. 1
Is the PRIME scheme similar to other regulatory licensing pathways?
The EMA’s PRIME scheme is similar to the Medicines and Healthcare Products Regulatory Agency’s (MHRA’s) UK specific Innovative Licensing and Access Pathway (ILAP).
Both PRIME and ILAP are designed to support medicinal products at earlier stages of development. During ILAP, the MHRA provides several services to help sponsors, including supporting the development of the target development profile.
Summary
The EMA’s PRIME scheme provides early and proactive regulatory support to developers of medicines targeting unmet medical needs, aiming to accelerate their approval. Recent updates introduced in 2023 enhance the scheme by implementing product development trackers, expedited scientific advice, and submission readiness meetings to improve efficiency.
