EMA and Heads of Medicines Agencies consult on common network strategy to 2020
Comments are invited up to 30 June 2015
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have released the ‘EU Medicines Agencies Network Strategy to 2020’, a draft common strategy for the European medicines agencies network, for a three-month public consultation. Stakeholders are invited to send in their comments before 30 June 2015.
The document outlines joint key priorities for the network and a strategy to achieve these.
The need to strengthen collaboration between network members and work together towards achieving agreed goals has become more urgent recently.
Europe faces the global threat of antimicrobial resistance to human and animal health, and needs to be prepared for emerging epidemics, as highlighted by the outbreak of Ebola virus disease in West Africa in March 2014.
At the same time the healthcare needs of patients in Europe are changing. Scientific and medical advances mean that new and more complex medicines are being developed, which may bring opportunities for personalised medicines and more treatments for rare diseases. Patients also require timely access to new, beneficial and safe medicines. The globalisation of the pharmaceutical industry means that greater collaboration with regulators beyond the European Union (EU) is essential to assure the supply of safe, effective and good quality medicines for humans and animals.
The joint strategy for the EU medicines agencies network is based on a coordinated approach and strengthened collaboration within the network over the next five years, to address the challenges and make the most of the opportunities to benefit human and animal health.
The joint strategy is based on a coordinated approach and strengthened collaboration within the network over the next five years
The network includes all national medicines regulatory authorities for both human and veterinary medicines from EU Member States and the European Economic Area (EEA), united in the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA). By working together, the network can draw on the resources and expertise available across the EU, avoid duplication and share workloads.
The draft strategy focuses on areas where collaboration within the network can make a real difference. It builds on the EMA roadmap to 2015 and the HMA strategy document 2011–15.
The draft network strategy has four key themes focusing on:
- human health
- animal health and human health in relation to veterinary medicines
- optimising the operation of the network
- the global regulatory environment
Separate work programmes/implementation plans for EMA, HMA, and coordination groups for mutual recognition and decentralised procedures, human and veterinary (CMDh and CMDv) will be developed to give detailed information on the work of each component of the network, and will also describe how the strategy will be taken forward.
