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:
- 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 (for human medicines only);
- Addressing emerging health
threats;
- 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
