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EMA outlines priorities for 2010–2015
Pharmaceutical Technology Europe
The EMA has launched a public consultation on its Road Map to 2015 — a strategic vision that lays out the agency's priorities for the next 5 years.
The EMA has launched a public consultation on its Road Map to 2015 a strategic vision that lays out the agency's priorities for the next 5 years.
The European Medicines Agency Road Map to 2015 will build on the agency's previous Road Map initiative between 2005 and 2010, which focused on improving the promotion and protection of public health, improving the regulatory environment for medicinal products, and helping to stimulate EU innovation and R&D. The new road map will build on current achievements, but will also take "due account of the changing environment in which the Agency will have to operate over the next 5 years."
The road map has also proposed three priority areas for future actions.
The first priority will be to address public health needs by stimulating R&D in areas of unmet medical need or for rare and neglected diseases. The agency also hopes to facilitate new approaches to the development of medicines and implement effective preparedness plans to cope with public health threats.
Secondly, the EMA has said it will prioritize facilitating access to medicines by addressing the high attrition rate during the development process. The EMA's model for the reassessment of the benefits and risks of medicines will be improved, along with the quality, scientific and regulatory consistency of the medicines review process.
The third priority will be to optimize the safe use of medicines. The EMA believes it will achieve this by strengthening the evidence of the benefits and risks of a medicine following its authorization, as well as by applying novel pharmacovigilance methodologies and risk minimization tools. Finally, the EMA explained that it would take patient experience into account for improved decision making and become a reference point for information about medicines evaluated by the agency.
As part of the public consultation process, the EMA has said it will hold a number of workshops and face-to-face discussions. Final adoption is expected in December 2010.