EMEA unveils Road Map to 2015 at TOPRA Symposium

Sweden 7-9 October – The Executive Director of the European Medicines Agency unveiled details of their Road Map to 2015 at the TOPRA Annual Symposium this week.

Thomas Lönngren announced that Road Map 2015 will be a continuation of Road Map 2010, building on current achievements, but also taking due account of the Agency’s business drivers which include public health needs, new and emerging science, increasing globalisation, models for the regulation of medicines, patient safety, transparency and openness.

Delegates received insight into the four strategic areas identified for the next five years, one of which will be to further improve the operation of the core business. Within this, there will be a focus on continuing to improve the quality and the regulatory and scientific consistency of the outcome of the scientific review. Mr Lönngren believes that one of the most important issues will be to improve the benefit/risk assessment, perhaps through a search for a more systematic model. A question from the floor raised: “With the possibility of a new way of analysing or ensuring benefit/risk, Industry needs to understand what this might be to understand how their documents and products will be evaluated. Is there a timeline that the EMEA foresees?” In response, Mr Lönngren informed delegates: “This will take many years, and there will be much necessary discussion to see how we could improve the decision making from the scientific point of view, because we cannot continue to do what we have done in the same way for the past 20 years…”

Mr Lönngren also noted that interaction with HTA bodies to improve access to medicines will be an important focus. The launch of the public consultation for the 2015 Road Map will be in January 2010.

The TOPRA Symposium was also given early insight to the new structural organisation at EMEA which is scheduled for completion in December 2009.

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