EMA released its draft of ‘Regulatory Science to 2025’

21 December 2018

GMP News

European Medicines Agency (EMA) has published its draft of ‘Regulatory Science to 2025’ strategy for a six-month public consultation. This is a proposed plan for advancing the Agency’s engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines.

The strategy will help shape the vision for the next EU Medicines Agencies Network Strategy (2020–2025). It seeks to offer informed guidance on modern medicines development, facilitate the optimization of regulatory science and critically assess the benefits and risks of innovative therapies and diagnostics based on new technologies. Stakeholders are invited to send their comments via an online questionnaire by 30 June 2019.

Guido RasiExecutive Director of EMA, commented:

“The Regulatory Science strategy to 2025 aims to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine. 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.”

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.

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.­


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