Agency foresees adaptation to encompass emerging technologies.
The European Medicines Agency (EMA) has published its final “Road Map to 2015”, setting out its vision for further developing its role, and building on the achievements of the previous road map initiative between 2005 and 2010. Publication of the Road Map to 2015 coincides with the 16th anniversary of EMA’s inauguration.
The new road map proposes three priority areas for future action. First, the agency aims to address public health needs by stimulating new approaches to drug development and the development of medicines for areas of unmet medical need, neglected and rare diseases, and all types of drugs for veterinary use. One way EMA hopes to encourage the development of new drugs for unmet needs and neglected and rare diseases is to work with the industry to find out the most common reasons for the discontinuation of some types of drug development—with an initial focus on specific orphan medicines—and how remedial action can be implemented. It suggests any solution should favor what it calls a holistic approach, including the use of novel endpoints, different study designs, and more appropriate use of accelerated assessment schemes.
It notes that one of the most critical areas of need relates to the limited availability of novel antibiotics for human use. To this end, EMA plans to launch initiatives to address the lack of new antibiotic development, and the potential threat of antimicrobial resistance arising from the use and misuse of antimicrobials.
Second, EMA wants to facilitate access to medicines, as well as address the high attrition rate during the medicines-development process, reinforce the benefit/risk-balance assessment model, and continue to improve the quality and the regulatory and scientific consistency of the outcome of scientific review. It stresses the importance of adapting the existing model for medicines regulation to enable the integration of new and emerging science. With respect to technological advancements in particular, EMA stresses that scientific progress over the next five years will be an important driver for change. It plans to build on its existing experience with emergent techniques including cell and gene therapies, and tissue engineering, to address new challenges relating to nanotechnologies, novel drug development approaches, synthetic biology, and regenerative and personalized medicine.
Third, priority is to be placed on optimizing the safe and rational use of medicines by strengthening the evidence base in the post-authorization phase to enable better regulatory decision-making and avoid unnecessary risks to patients as a result of drug use. It also wants to become more of a reference point for information on medicines it has evaluated, and improve the decision-making process by taking due account of patient experience.
The EMA Road Map to 2015 has been drafted in consultation with the agency’s European partners, stakeholders (including patients’ and doctors’ organizations as well as pharmaceutical industry), and the public.