EMA PRIME Scheme Explained: Eligibility, Benefits, Risks, and When to Apply

What Is the EMA PRIME Scheme?

The European Medicines Agency (EMA) launched the PRIME (PRIority MEdicines) medicines scheme in March 2016 to accelerate development of medicines addressing high unmet clinical needs, especially innovative or rare disease therapies. PRIME provides early appointment of a CHMP/CAT rapporteur, PRIME scientific coordinator, multi-disciplinary kick-off meeting, iterative scientific advice/protocol assistance, submission readiness meeting and early confirmation of potential accelerated assessment eligibility through centralized EMA coordination.

In 2024, EMA received 58 PRIME eligibility requests and adopted 56 recommendations, of which 15 products were granted access to the Scheme; an approval rate of 27% (EMA Annual Report 2024). CHMP recommended six PRIME designated products for approval in 2024 including Beqvez (subsequently withdrawn), Fabhalta, Ixchiq, Seladelpar Gilead, Voydeya and Winrevair.

• Note: “Recommended” = CHMP opinion; EC decisions followed on varying dates.
• As of 25 November 2025, 15 products have already been granted access to the scheme.

EMA PRIME Eligibility Criteria and Acceptance Rates

What are the Benefits of the EMA PRIME Designation for Drug Developers?

What are Potential Limitations and Risks of the EMA PRIME Scheme?

While PRIME designation offers early and tailored regulatory support, it’s important to understand its limitations. Guidance under PRIME typically comes from a single rapporteur, which some stakeholders feel is less comprehensive than scientific advice provided by the Scientific Advice Working Party (SAWP). Moreover, PRIME status does not guarantee a smooth marketing authorization (MA) process; major objections can still be raised by other member states during evaluation.

Finally, although accelerated assessment timelines aim to shorten approval, they are highly demanding, and many products ultimately revert to the standard assessment schedule. In short, PRIME can be a valuable tool, but it is not a shortcut; robust planning and data quality remain essential for success.

Timing and Evidence Requirements for EMA PRIME Applications

Does EMA PRIME Accelerate Drug Approval Timelines?

The overall aim of the PRIME scheme to bring the most promising of medicines to patients with unmet medical needs ultimately does work, as borne out by the data. Recent work by Alaburde and colleagues (2025) demonstrated that for ATMPs, PRIME designation reduced time from start of MA procedure to final European Commission approval by 42.7% (i.e., approximately 1 year reduction – median of 376 days for PRIME vs 669 days for non-PRIME products). This improved timeline is associated with fewer clock stops (2 vs 3 for PRIME vs non-PRIME), shorter clock stops (99 days vs 358 days 3 for PRIME vs non-PRIME), as well as many more scientific advice/protocol advice meetings which may help to iron out defects during clinical development (4.5 vs 2.0 for PRIME vs non-PRIME).

The ‘submission readiness’ meeting offered as part of PRIME to discuss dossier maturity is also a factor to smooth out remaining issues ahead of dossier submission. As well as a more streamlined MA assessment, PRIME-designated products are also judged to have shorter clinical development timelines (EMA 5 year PRIME review, 2022).

How will EMA PRIME Impact the EU Pharma Package?

European co‑legislators reached a political deal on the “pharma package” (Dec 11, 2025), recalibrating data/market protection, introducing supply obligations for protected medicines, and expanding the Bolar exemption; measures aimed at access, competition, and resilience. As of now, no explicit, agreed‑text changes to PRIME’s scope have been communicated publicly; sponsors should monitor implementation details as they emerge.

As international regulatory continue to collaborate and information share in our increasingly global regulatory environment, international collaboration among expedited regulatory pathways (such as EMA’s PRIME, Japan’s PMDA Sakigake System, FDA’s Breakthrough Therapy designation, and MHRA’s Innovative Licensing and Access Pathway [ILAP])is increasingly critical to accelerate patient access to transformative medicines.

These programs share common goals of fostering early dialogue, providing scientific advice, and enabling streamlined development for therapies addressing high unmet medical needs. By aligning principles and promoting regulatory convergence, agencies can reduce duplication, support global clinical strategies, and ensure timely availability of innovative treatments across regions.

Global Expedited Access Pathways and Regulatory Convergence

References

1. EMA Annual report 2024. Available at: https://www.ema.europa.eu/en/documents/annual-report/2024-annual-report-european-medicines-agency_en.pdf. Last accessed 25 November 2025.
2. Alaburde S, Ivaska J, Kaspute G, Ivaskiene T. Impact of regulatory measures on the approval timelines of advanced therapy medicinal products by the European Medicines Agency. Front Med (Lausanne). 2025;12:1623689. Published 2025 Jun 26. doi:10.3389/fmed.2025.1623689.
3. EMA report on PRIME - Analysis of the first 5 years’ experience. 2022. Available at: https://www.ema.europa.eu/system/files/documents/report/2022-03_prime_5_years_report_updated_2022-04-05-en.pdf Last accessed 27 November 2025.
4. ‘Pharma package’: Council and Parliament reach a deal on new rules for a fairer and more competitive EU pharmaceutical sector. https://www.consilium.europa.eu/en/press/press-releases/2025/12/11/pharma-package-council-and-parliament-reach-a-deal-on-new-rules-for-a-fairer-and-more-competitive-eu-pharmaceutical-sector/