Introduction
The European Medicines Agency’s (EMA) PRIority Medicines (PRIME) scheme plays a central role in supporting the development of innovative medicines that address unmet medical needs. Through early scientific and regulatory support, PRIME helps medicine developers optimise development programmes and accelerate patient access to promising therapies across the European Union (EU).
At the same time, the EU pharmaceutical landscape is undergoing major reform through the proposed revision of the EU pharmaceutical legislation. These changes are expected to reshape several regulatory pathways and incentives, including the PRIME scheme. For pharmaceutical and biotechnology companies, understanding how PRIME may evolve under the new legislation will be critical for future regulatory strategy, clinical development planning, and market access preparation.
In this blog, we explore the current PRIME framework, examine how the revised pharmaceutical legislation may impact the scheme, and discuss what these changes could mean for medicine developers navigating the evolving EU regulatory environment.
To learn more about EU pre-approval regulatory requirements, PRIME, and the upcoming legislative changes expected to impact medicine development and regulatory strategy, watch our webinar: ‘Future-proofing your EU regulatory deliverables and the impact of the revised pharmaceutical legislation on medicine development’.
The new pharmaceutical legislation
In April 2023, the European Union (EU) undertook a comprehensive evaluation of the pharmaceutical legislation. It adopted a proposal for a new pharmaceutical Directive (2023/0132)1 and a new Regulation (2023/0131)2, which revise and replace the existing general pharmaceutical legislation (Directive 2001/83/EC3 and Regulation (EC) No 726/20044). This evaluation also included a proposal to repeal the existing Orphan Medicinal Products Regulation (EC) No 141/20005, and the Paediatric Regulation (EC) No 1901/20066, and to identify strengths and areas for improvement in a new regulation.
On the 11th of December 2025, the EMA announced that the European Parliament and the Council of the European Union reached a political agreement on the reform of the EU pharmaceutical legislation. It is now undergoing a formal review by the European Parliament and the Council.
The proposed new pharmaceutical legislation has far-reaching effects on several regulatory deliverables across all stages of pre-approval medicine development. We will focus on the changes to the EMA’s PRIME scheme.
The EMA’s PRIority MEdicines scheme
The EMA’s PRIME scheme offers early regulatory support to accelerate the development of innovative medicines addressing unmet medical needs.
Launched in 2016, PRIME provides early and proactive support to developers of promising new medicines aiming to address unmet medical needs in a two-pronged approach:
- 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.
Admission onto the PRIME scheme is competitive and requires data from a clinical proof-of-concept trial (Phase 2), showing an unambiguous benefit. Essentially, applicants who apply for PRIME designation, having started a registrational trial, will likely be denied.
Image source: Somerville Development Partners
Sponsors who are granted PRIME are provided with:
- A Rapporteur and EMA PRIME Scientific Coordinator to provide advice and support.
- A PRIME kick-off meeting offering specific guidance on the overall development plan, guideing scientific advice and regulatory strategy.
- Iterative scientific advice including expedited follow-up advice under certain criteria.
- A submission readiness meeting 1 year ahead of an MAA submission.
In 2023, the EMA introduced several new features to the PRIME scheme, and we detailed the EMA’s latest updates to PRIME in a blog: What has changed with PRIME?
How will the new pharmaceutical legislation change the PRIME scheme?
Per Article 60 of Regulation 2023/01012, the EMA may offer enhanced scientific and regulatory support and accelerated assessment for certain medicinal products that, based on preliminary evidence you submit, fulfil at least one of the following conditions:
- Are likely to address an unmet medical need, as referred to in Article 83(1) of revised Directive1 and are expected to be of major interest from the point of view of public health, in particular as regards therapeutic innovation, taking into account the early stage of development, or
- Are antimicrobials with any of the characteristics mentioned in Article 40(3) (see section below on priority antimicrobials) or provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or taking into account as a priority any equivalent list of priority pathogens adopted at Union level;1 or
3) are likely to target a neglected tropical disease (NTD).1
Priority antimicrobials
The revised pharmaceutical regulation outlined that an antimicrobial will be considered ‘priority antimicrobial’ if it addresses a multi-drug resistant organism and if the preclinical and clinical data demonstrate a significant clinical benefit with respect to antimicrobial resistance, and if it has at least one of the following characteristics, as mentioned in Article 40(3) of the proposed regulation:2
- Its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union.2
- It contains an active substance that when used either alone or in combination with other active substances addresses serious or life-threatening infection.2
Priority antimicrobials will also benefit from a transferable by sale 1-year exclusivity extension voucher, per Article 40 of the proposed regulation.2
Summary
The proposed revision of the EU pharmaceutical legislation represents one of the most significant regulatory updates in recent years and is expected to have important implications for the EMA’s PRIME scheme. While PRIME will continue to focus on supporting medicines that address unmet medical needs, the new legislation may introduce changes to eligibility criteria, regulatory incentives, and development expectations for sponsors.
For pharmaceutical and biotechnology companies, staying informed about these developments will be essential for effective regulatory planning and long-term development success. By understanding how the PRIME framework may evolve, organisations can better position themselves to maximise opportunities for accelerated development and navigate the future EU regulatory landscape with greater confidence.
How Somerville Development Partners can help
Our team brings decades of combined experience across both consultancy and industry settings. This dual perspective enables us to balance regulatory rigour with scientific and operational realities.
We don’t just advise, we embed within your team to deliver high-quality regulatory solutions to help pharmaceutical and biotech companies develop safe and efficacious medicines for patients.
Whatever your needs, we are your trusted life sciences partner:
Long-term (12–24 months) projects, such as an MAA, new drug application or biologics license application.
Ad-hoc or complex development services such as regulatory due diligence, paediatric development or orphan designation if you are developing medicines for rare diseases.
Short-term (3–6 months), discrete projects to address a particular need for resources or expertise.
