Regulatory science strategy

The European Medicines Agency's (EMA) 'Regulatory Science to 2025' strategy is a plan for advancing EMA's engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines. The strategy aims to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine. EMA consulted with stakeholders on the draft strategy via a public consultation and dedicated workshops.

Regulators need to have optimal tools to keep pace with scientific and technological advances and ensure the sound assessment of ground-breaking, more complex therapies.

‘Regulatory science’ refers to the range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied biomedical and social sciences and contributes to the development of regulatory standards and tools.

Regulatory Science Strategy to 2025

On 31 March 2020, EMA published its Regulatory Science Strategy to 2025 after it was endorsed by EMA's Management Board at its March 2020 meeting.

EMA Regulatory Science to 2025 - Strategic reflection

Adopted

The five key goals of the strategy include:

• catalysing the integration of science and technology in medicine development;
• driving collaborative evidence generation to improve the scientific quality of evaluations;
• advancing patient-centred access to medicines in partnership with healthcare systems (for human medicines only);
• addressing emerging health threats;
• enabling and leveraging research and innovation in regulatory science.­

The strategy seeks to offer informed guidance on modern medicines development, facilitate the optimisation of regulatory science and critically assess the benefits and risks of innovative therapies and diagnostics based on new technologies.

It identifies key areas where new or enhanced engagement of the European medicines regulatory network is essential and where advances in regulatory science are necessary. It also helps to shape the vision for the next EU Medicines Agencies Network Strategy (2020 - 2025).

Strategy roadmap

Infographic - Development of the regulatory science strategy to 2025

An overview of planned activities and their timeline. From baseline review and horizon scan (2017–2018) to the final regulatory science strategic reflection (2020).

Mid-point achievements report

A report is available on the progress made in implementing the goals of the Regulatory Science Strategy.

This mid-point achievements report covers the period between March 2020 and December 2022.  

It highlights achievements related to both human and veterinary recommendations laid out in the strategy.

Achievements include:

• The Clinical Trials Information System (CTIS)
• The Accelerating Clinical Trials in the EU (ACT EU)
• DARWIN EU
• The Union Product Database

EMA published this report in March 2023.

EMA’s Regulatory Science Strategy to 2025 - Mid-point achievements to end 2022

Reference Number: EMA/211551/2022

Consultation process

On 31 March 2020, EMA published a summary and corresponding analysis of the key points raised during the public consultation.

Analysis and summaries of public consultation results: EMA Regulatory Science to 2025 - Strategic reflection

In preparation for the launch of its draft 'Regulatory science to 2025' strategy, EMA organised two workshops, where participants reflected on the scientific and technological advances in the pharmaceutical arena, and the future challenges that EMA’s scientific committees and working parties will face due to these developments. For more information, including supporting materials, see:

• Multistakeholder workshop to launch consultation on European Medicines Agency (EMA) human regulatory science to 2025 (24/10/2018)
• Multi-stakeholder workshop to launch consultation on European Medicines Agency (EMA) veterinary regulatory science to 2025 (06/12/2018)

In December 2018, EMA started a six-month public consultation on its draft strategic reflection on the regulatory science strategy to 2025, to gather feedback from stakeholders. Around 150 individuals and organisations submitted comments, which are available below:

• EMA Regulatory Science to 2025 - responses to the online questionnaire

Draft EMA Regulatory Science to 2025 - Strategic reflection

Consultation dates: 19/12/2018 to 30/06/2019Draft: consultation closedSummary:

The Regulatory Science strategy to 2025 aims to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine,” said Guido Rasi, EMA’s Executive Director. “The strategy includes developments and challenges in medicines development that we together with the Commission and NCAs experts have identified in a thorough process of mapping and selection. Now we want to hear from our stakeholders whether they consider this strategy is ambitious enough.”

Stakeholders are invited to send their comments via an online questionnaire by 30 June 2019.

EMA subsequently organised separate human and veterinary medicines workshops to consult stakeholders on the outcome of the analysis of the public consultation and identify concrete actions in order to implement the key goals and recommendations. 

The workshops brought together representatives from EMA's regulatory partners and stakeholders, including national competent authorities, patients’, healthcare professionals’ and veterinarians’ organisations, health technology assessment bodies, payer organisations and the pharmaceutical industry. For more information, see:

• Multi-stakeholder workshop on draft 'Regulatory Science to 2025' strategy (stakeholders for hum [...] medicines) (18-19/11/2019)
• Multi-stakeholder workshop on draft 'Regulatory Science to 2025' strategy (stakeholders for vet [...] medicines) (05-06/12/2019)