EMA outlines priorities for 2010–2015

The European Medicines Agency (EMA) launched a public consultation on its Road Map to 2015-a strategic vision that lays out the agency's priorities for the next five years.

The European Medicines Agency Road Map to 2015, released this week, will build on the agency's previous Road Map initiative for 2005-2010, which focused on improving the promotion and protection of public health, improving the regulatory environment for medicinal products, and helping to stimulate European Union innovation and research and development (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 five years."

The road map proposes three priorities. The first priority is to address public-health needs by stimulating R&D in areas of unmet medical need and for rare and neglected diseases. The agency also hopes to promote new approaches to the development of medicines and implement effective preparedness plans to cope with threats to public health.

Second, EMA will expand access to medicines by addressing the high attrition rate of the drug-development process. EMA will improve its model for reassessing the benefits and risks of medicines, along with the quality, scientific, and regulatory consistency of the medicine-review process.

The third priority is to optimize the safe use of medicines. EMA will strengthen the evidence of the benefits and risks of a drug following its authorization and also apply novel pharmacovigilance methodologies and risk-minimization tools. Finally, EMA will take patient experience into account for improved decision-making and become a reference point for information about medicines.

As part of the public consultation process, EMA will hold several workshops and face-to-face discussions. Final adoption of the Road Map is expected in December 2010, according to an agency press release.