Regulatory Science to 2025
The European Medicines Agency's (EMA) draft '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 draft strategy aims to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine. EMA has been consulting 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.
EMA published its draft strategy in December 2018 for a six-month public consultation:
Update: Around 150 individuals and organisations submitted comments, which EMA has published in a partially anonymised format:
EMA is in the process of analysing the comments. It plans to publish the analysis in November 2019.
EMA will finalise the draft strategy following further consultation with stakeholders as part of two stakeholder workshops to be held in late 2019.
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 draft 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).
EMA is organising separate human and veterinary medicines workshops to consult stakeholders on its draft 'Regulatory science to 2025' strategy.
The workshops bring 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.
Update: Two stakeholder workshops in late 2019 will discuss the outcome of the analysis of the public consultation and identify concrete actions in order to implement the key goals and recommendations. For more information, see:
The draft strategy released for public consultation incorporated feedback from stakeholder workshops in 2018, 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: