EMA Outlines Priorities To 2015

The European Medicines Agency (EMA) has published its final ‘Road map to 2015’, a document that sets out the agency’s key drivers for progress and strategic vision of operation for the next 5 years. The agency plans to prioritize public health needs, improving access to medicines, and optimizing the safe and rational use of medicines.

The road map builds on previous initiatives between 2005 and 2010 and proposes the following three priority areas:

• Addressing public-health needs: stimulating medicines development in areas of unmet medical needs, neglected diseases and rare diseases, and for all types of medicines for veterinary use; facilitating new approaches to medicines development; applying a more proactive approach to public-health threats where medicines are implicated.
• Facilitating access to medicines: addressing the high attrition rate during the medicines-development process; reinforcing the benefit/risk-balance assessment model; continuing to improve the quality and the regulatory and scientific consistency of the outcome of the scientific review.
• Optimizing the safe and rational use of medicines: strengthening the evidence base in the post-authorization phase; 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; improving the decision-making process by taking due account of patient experience.

Industry challenges

The road map is a response to some of the key drivers for progress and change that are affecting the EMA. Since the road map to 2010, the EMA explained that its roles and responsibilities have expanded to cover more activities. For instance, new legislative provisions from the European Commission concerning falsified medicines and pharmacovigilance will have important consequences for the EU regulatory network and the EMA in particular given its coordinating role.

The EMA is also concerned by emerging public health challenges, such as demographic changes, antimicrobial resistance, climate change (particularly in view of the emergence of new diseases) and the rapid development of new technologies, including e-health). Additionally, there is a need to further develop the regulatory framework for new and emerging science, such as personalized medicine, nanotechnologies, regenerative medicines and synthetic biology, with respect to benefit/risk evaluation, potential safety issues, and ethical and environmental considerations.

The EMA has also noted the growing public demand for greater transparency, particularly with regards to the availability of up-to-date information on medicinal products, adverse drug reactions and clinical trials. However, the EMA also added that this will be a challenge. “Providing greater transparency will entail specific challenges, such as finding the right balance between making more information and documents available more quickly and protecting commercially confidential information, while also complying with personal-data legislation,” said the road map.

Detailed information about the implementation of the road map will be published in a separate document entitled From vision to reality. This document will provide information on the required prerequisites and the enablers (including operational and organisational aspects).

To optimize the implementation of the road map, the EMA will also complement its planning process by applying a multi-annual programming approach that will address aspects such as workload and resources forecasts and budget planning.

www.ema.europa.eu