EMA Holds Stakeholder Workshop on Draft Regulatory Science Strategy

The European Medicines Agency (EMA) hosted a multi-stakeholder workshop earlier this month (November 18 and 19) on its draft policy document, “Regulatory Science Strategy to 2025.”

The draft strategy sets out working proposals on the key areas with which EMA intends to engage in order to ensure that it has the regulatory tools to continue supporting the European medicines regulatory network and fulfil its ongoing mission in light of upcoming scientific challenges. The final strategy, expected in early 2020, will be a key contribution to the next EU Medicines Agencies Network Strategy (2020-2025) in addition to the agency’s scientific committees’ and working parties’ workplans through to 2025.

The EMA’s “Regulatory Science Strategy to 2025” was released for public consultation between December 2018 and June 2019. Around 150 individuals and organizations across a broad range of stakeholder groups submitted comments, which the EMA has published in a partially anonymized format. The principle objective of the consultation was to allow stakeholders to engage with the proposed strategy and express their views on future priorities and where resources should be best attributed.

A second workshop with stakeholders for veterinary medicines will take place at the EMA December 5 and 6, after which the strategy will be finalized. More details on this workshop will be communicated shortly. The presentations and audio recordings of both workshops will be published.

Five main goals of its strategy are: (1) catalyzing the integration of science and technology in medicine development; (2) driving collaborative evidence generation by improving the scientific quality of evaluations; (3) advancing patient-centered access to medicines in partnership with healthcare systems; (4) addressing emerging health threats and availability/therapeutic challenges; and (5) enabling and leveraging research and innovation in regulatory science.

Participants in the multi-stakeholder workshop held earlier this included patient representatives, healthcare professionals, academia, health technology assessment bodies, payers organizations, trade associations and regulators. The purpose of the workshop was to discuss the outcome of the public consultation on the draft strategy, reflect on the prioritization of core recommendations, and identify concrete actions to implement the key goals and recommendations.

Source: European Medicines Agency


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