HMA Strategy Paper II: Environmental analysis (draft structure)

The European Medicines Agency (EMA) has published it final Road Map to 2015, which proposes three priority areas for future actions by the Agency.

Building on the achievements of the previous 2005-2010 Road Map, the new initiative seeks to strengthen the Agency's role though:

• addressing public health needs by: - 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 by: - addressing the high attrition rate during the medicines development process; - reinforcing the benefit/risk-balance assessment model; - and continuing to improve the quality and the regulatory and scientific consistency of the outcome of the scientific review; and

• optimising 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 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 EMA cautions that successful delivery of this vision is dependent on the availability of the necessary resources.Detailed information on implementation of the Road Map - which has been drafted in consultation with the Agency’s European partners and stakeholders, including patient and doctor organisations, the pharmaceutical industry and the public - will be provided in a document entitled From Vision to Reality, which wil be published in the course of 2011, it says. 

The Heads of Medicines Agencies (HMA) have also drawn up their own 2011-15 Strategy for the European Medicines Regulatory Network which, they emphasise, is intended to complement and not duplicate the EMA Road Map.

The aim of the new HMA Strategy is to identify the key challenges which will face the Network over the next five years and how it can best respond to these challenges, thus:

• safeguarding public and animal health, particularly through: - strengthening surveillance of the benefits and risks of medicines in the European population including by improving spontaneous reporting systems to enable early detection of risks; - good communication, including work on the HMA website; and - strengthened monitoring of the quality of medicines including risk-based redeployment of inspections;

• Supporting innovation, particularly through: - efficient and proportionate regulation of new medicines and clinical trials, eg by using the Voluntary Harmonisation Procedure (VHP); and - the provision of scientific and regulatory advice; and

• further improving the operational efficiency of medicines authorisation by the Decentralised and Mutual Recognition Procedures (DCP/MRP), particularly through: - identifying with stakeholders areas to address and more targeted communication; - risk-based proportionate regulation; - harmonisation of assessment; - work-sharing; -  harmonised training; - ensuring interoperability of national information technology (IT) systems within the European network, creating a competitive, boundary-free regulatory environment; and - dialogue with industry.