EMA's public consultation - strategic reflection paper on Regulatory Science to 2025

On 19 December the European Medicines Agency (EMA) published its strategic reflection paper on Regulatory Science to 2025.

This strategic reflection paper aims at advancing the EMA’s engagement with regulatory science over the next five to ten years. The document covers both human and veterinary medicines.

The term “Regulatory science”refers to the range of scientific disciplines which assess the quality, safety and efficacy of medicinal products and inform regulatory decision-making throughout the lifecycle of a medicine. It includes basic and applied biomedical and social sciences and contributes to the development of regulatory standards and tools.

Strategic goals:

The strategic goals for human medicines are the following:

  1. Catalysing the integration of science and technology in medicines development;
  2. Driving collaborative evidence generation - improving the scientific quality of evaluations;
  3. Advancing patient-centred access to medicines in partnership with healthcare systems (for human medicines only);
  4. Addressing emerging health threats;
  5. Enabling and leveraging research and innovation in regulatory science.

For each key goal, the plan suggests core recommendations and corresponding actions.

Among the recommendations, the EMA calls for:

  • Leveraging non-clinical models and 3Rs[1]principles;
  • Fostering innovation in clinical trials;
  • Developing the regulatory framework for emerging clinical data generation;
  • Optimising capabilities in modelling, simulation and extrapolation;
  • Exploiting digital technology and AI in decision making;
  • Supporting HTA preparedness and decision making for innovative medicines;
  • Developing network-led partnerships with academia to undertake fundamental research in strategic areas of regulatory science;
  • Leveraging collaborations between academia and network scientists to address rapidly emerging regulatory science research questions;
  • Identifying and enable access to the best expertise across Europe and internationally;
  • Disseminating and exchanging of knowledge, expertise and innovation across the network and its stakeholders;
  • Creating an integrated evaluation pathway for the assessment of medical devices, in vitro diagnostics and borderline products;
  • Developing a better understanding of, and regulatory response, to nanotechnology and new materials in pharmaceuticals.

Next steps

Comments and feedback on this strategic reflection paper can be submitted through a public questionnaire that was opened by the EMA until the 30 June 2019. The consultation will be put to further discussion in the Avicenna’s Policy Development Working Group to consider a reply.

For more information, the document is available here and the EMA’s press release here.


[1] Replacement, Reduction and Refinement


Date: 11/02/2019 | Tag: | News: 907 of 1007
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