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RSNN responds to EMA’s draft strategy ‘Regulatory Science to 2025’

24 July 2019
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The RSNN is very excited about the draft strategy and foresees significant contributions to innovating and improving regulatory science.

In December 2018, the European Medicines Agency (EMA) published its draft strategy ‘Regulatory Science to 2025’, describing the plan for advancing EMA’s engagement with regulatory science over the next five to ten years. The draft was published for a public consultation, in which EMA stakeholders can share their views on the strategic document. The RSNN has formulated a response on the human medicines part of this strategic document.

The RSNN is very excited about the draft strategy and foresees significant contributions to innovating and improving regulatory science. RSNN’s main recommendation is about strengthening the exchange of scientific information and dialogue with all stakeholders. The challenges set out in the strategic document are ones we need to tackle with society as a whole to realize the potential that is contained within this strategic document.

According to the RSNN, two significant elements are lacking in EMA’s strategic document. First, EMA’s definition of regulatory science does not prioritize research of the regulatory system itself. And secondly, a reflection on the development and methodological strengthening of regulatory science itself is missed. Ultimately, regulatory science is not only about informing regulatory decision making and developing regulatory standards and tools, but also about researching and providing insight for improvement of the regulatory system itself.

This response was created and submitted by the RSNN as a collective and does not necessarily represent the views of its individual partners.