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. In December 2018, EMA published the draft strategy for a six-month public consultation. 

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.

Public consultation

EMA published its draft strategy in December 2018 for a six-month public consultation:

EMA invites stakeholders to send comments by 30 June 2019 using the online questionnaire.

“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.”

Key goals

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 (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).

Stakeholder workshops

The draft strategy incorporates feedback from two stakeholder workshops in 2018 focusing on human medicines and veterinary medicines. These 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.

Participants at both workshops 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:

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