EMA releases its regulatory strategy for next five years

The European Medicines Agency (EMA) has published its Regulatory Science Strategy to 2025, which provides a plan for advancing regulatory science over the next five years.

According to the organisation, this comes in response to the dramatic acceleration of the pace of innovation in recent years and the need for regulators to be ready to support the development of increasingly complex medicines that combine different technologies.

The EMA also says that the ongoing COVID-19 pandemic will aid in the global understanding of public health crises and the learnings from the coronavirus outbreak will be incorporated to the new strategy so that processes can be adapted in real-time. 

“This key strategy was developed with the input of a wide range of our stakeholders,” said Guido Rasi, the EMA’s Executive Director. “I am confident that it will enable us to take a leadership position on new developments, identify the gaps between science and healthcare systems and bring together the various stakeholders needed to bridge those gaps.”

The strategy also sets out key areas where new or enhanced engagement of the European medicines regulatory network is essential and where advances in regulatory science are necessary. The document identifies strategic goals for such engagement for medicines and proposes core recommendations and underlying actions to support these.

The five key goals of the strategy include:

• 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
• addressing emerging health threats and availability/therapeutic challenges
• enabling and leveraging research and innovation in regulatory science.

“The goals and the recommendations and actions stemming from them aim to ensure that regulators can advance public health and provide European citizens with optimal medicines regulation in the coming years,” writes the EMA in a statement.