The European Medicines Agency’s (EMA) has launched a six-month public consultation on the draft ‘Regulatory Science to 2025’ strategy, the plan for advancing EMA’s engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines published in December 2018.
All the stakeholders are invited to send comments by 30 June 2019 using the online questionnaire.
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.