Press release 31/03/2020

EMA has published its PDF iconRegulatory Science Strategy to 2025  today. The strategy provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It comes in response to the dramatic acceleration of the pace of innovation in recent years and the need for regulators to be ready to support the development of increasingly complex human and veterinary medicines that combine different technologies. The ongoing COVID-19 pandemic underlines the need for rapid and close engagement of all stakeholders and partners involved in the development and supervision of medicines in the European Union and globally, which is one of the fundamental principles of this strategy. The learnings from the handling of this public health crisis will be incorporated so that we can adapt our process in real-time, where needed.

The Regulatory Science Strategy to 2025 was adopted by EMA’s Management Board at its March 2020 meeting.

“This key strategy was developed with the input of a wide range of our stakeholders,” said Guido Rasi, EMA’s Executive Director. “I am confident that it will enable us to take a leadership position on new developments, identify the gaps between science and healthcare systems and bring together the various stakeholders needed to bridge those gaps.”

The strategy sets out key areas where new or enhanced engagement of the European medicines regulatory network is essential and where advances in regulatory science are necessary.

The document identifies strategic goals for such engagement for human and veterinary medicines and proposes core recommendations and underlying actions to support these.

The five key goals of the strategy include:

  • catalysing the integration of science and technology in medicines development;
  • driving collaborative evidence generation – improving the scientific quality of evaluations;
  • advancing patient-centred access to medicines in partnership with healthcare systems;
  • addressing emerging health threats and availability/therapeutic challenges;
  • enabling and leveraging research and innovation in regulatory science.

The goals, and the recommendations and actions stemming from them, aim to ensure that regulators can advance public health and provide European citizens with optimal medicines regulation in the coming years.

The Regulatory Science Strategy will feed into the overarching European Medicines Regulatory Network Strategy to 2025, which is currently being developed together with the Member States, the European Commission and EMA’s stakeholders and will guide the work carried out by EMA and the national agencies in the coming years. Deliverables of the Regulatory Science Strategy will also be embedded in EMA’s multiannual work programmes and implementation plans of EMA’s scientific committees, working parties and other groups involved in medicine evaluation.

The Regulatory Science Strategy to 2025 was developed in 2018 and 2019 in consultation with a wide range of stakeholders, including healthcare professionals, patients, pharmaceutical industry, academia, and other regulatory bodies, who provided their views on the core recommendations and supporting actions outlined in the strategy.

PDF iconAnalysis and summaries of the public consultation results have been distilled into a comprehensive document also published today.