The European Medicine Agency (EMA) has published its draft on a “Regulatory Science to 2025” strategy for public consultation.
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. The proposed 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.
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.
Stakeholders are now invited to send their comments by 30 June 2019 via an online questionnaire. (survey opens on https://ec.europa.eu)
For more information, please consult the EMA press release