EMA’s Regulatory Science Strategy to 2025

Reshaping regulatory science

The European Medicines Agency (EMA) hosted on 24 October 2018 a workshop to gather insight from stakeholders on the key areas in human medicines to be covered in its ‘Regulatory Science Strategy to 2025’, a proposed new high-level plan for advancing its engagement with regulatory science.

The workshop offered an opportunity to reflect on the scientific and technological advances in the pharmaceutical arena, the challenges that the Agency’s scientific committees and working parties will face in the future and to look at initial proposals to address them. It also highlighted areas relevant to various stakeholder groups in advance of a six-month public consultation on the proposed strategy to be launched in December 2018.

“The pace of innovation has accelerated dramatically in recent years and regulators need to be ready to support the development of increasingly complex medicines that more and more deliver healthcare solutions by converging different technologies to promote and protect human and animal health,” said Guido Rasi, EMA’s Executive Director. “Also, big data will open up new sources of information on the use of medicines in the real word, and we need to take urgent action to address the challenges arising from collecting and processing this personal data from patients. This will inform the network’s regulatory science strategy and help us to keep on top of developments, identify the gaps between science and healthcare systems and bring together the various stakeholders needed to bridge those gaps.”

Participants included patients, healthcare professionals and academia, as well as representatives of health technology assessment bodies, payer organisations, trade associations and regulators. The workshop kicked off discussions on how to best reshape the regulatory environment so that EMA, working as part of the European medicines regulators network, can support advances coming through research and development pipelines in the coming years.

Key priorities of the Regulatory Science Strategy to 2025

The ‘Regulatory Science Strategy to 2025’ will identify key areas where new or enhanced engagement of the network is essential and where advances in regulatory science will need to be adopted.

The strategy will help shape the vision for the next EU Medicines Agencies Network Strategy (2020–2025). It will seek to offer informed guidance on modern product development, facilitate the optimisation of regulatory tools to improve the various processes and critically assess the benefits and risks of innovative therapies and diagnostics based on new technologies.

The five key goals of the strategy include:

  • catalysing the integration of science and technology in medicine 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.

Regulatory science is defined as 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.