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The European Medicines Agency published its final ‘Road map to 2015’, coinciding with the 16th anniversary of its inauguration on 26 January 2011.
The ‘Road map to 2015′ sets out the Agency’s vision in further developing its role as a European public-health agency in the field of medicines.
Building on the achievements made by the previous road map initiative between 2005 and 2010, the new road map proposes three priority areas to strengthen the Agency’s role in protecting and promoting human and animal health in the European Union.
Public-health needs should be addressed by: stimulating medicines development in areas of unmet medical need, such as neglected and rare diseases, and all types of medicines for veterinary use; facilitating new approaches to medicines development; and applying a more proactive approach to public-health threats where medicines are implicated.
The Agency plans to facilitate access to medicines by: addressing the high attrition rate during the medicines-development process; reinforcing the benefit/risk-balance assessment model; continuing to improve the quality, regulatory and scientific consistency of the outcome of the scientific review.
Finally, it will attempt to optimise the safe and rational use of medicines by: strengthening the evidence base in the post-authorisation phase to enable better regulatory decision-making; enhancing patient safety by avoiding unnecessary risks to patients as a result of the use of medicines; becoming a reference point for information on medicines evaluated by the Agency; and improving the decision-making process by taking due account of patient experience, thus contributing to the rational use of medicines.
The road map has been drafted in consultation with the Agency’s European partners, stakeholders, including patients’ and doctors’ organisations as well as pharmaceutical industry, and the public, to ensure a broad consensus on the best approach to be taken for the Agency to fulfil its public mandate to protect and promote public health in the European Union over the coming years.
In developing its road map, the Agency continues to ensure that its vision is consistent with and complementary to strategic directions provided by the European Commission, the Council of the European Union and the Heads of Medicines Agencies.