The European Medicines Association (EMA) has published its “Regulatory Science Strategy to 2025”, which provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines.
The Strategy responds to the pace of innovation in recent years and the need for regulators to support the development of increasingly complex medicines that combine different technologies. The document identifies strategic goals for such engagement, proposing core recommendations and underlying actions to support these. The five key goals are:
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Catalysing the integration of science and technology in medicines development
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Driving collaborative evidence generation - improving the scientific quality of evaluations
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Advancing patient-centred access to medicines in partnership with healthcare systems
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Addressing emerging health threats and availability/therapeutic challenges
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Enabling and leveraging research and innovation in regulatory science.
The strategy will feed into the EMA’s overarching EMA “Regulatory Network Strategy to 2025”, which is currently under development. Additionally, its deliverables will be embedded in EMA’s multiannual work programmes and implementation plans of EMA’s scientific committees. You can find more information and the full regulatory strategy here:
