EU Medicines Agencies Network Strategy to 2020

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have adopted a common strategy to 2020 for the European medicines regulatory network. The strategy outlines joint key priorities and a high-level roadmap to achieve these, for the first time.

By following the same strategy, the European regulatory network should be able to tackle current and future challenges more effectively:

EMA and HMA published the final strategy in December 2015.

The strategy focuses on strategic priority areas where the network can make a difference to human and animal health in the EU to 2020 and is built around four key themes:

  • human health, by encouraging and supporting the development of new medicines addressing real public health needs and ensuring the ongoing availability of existing medicines;
  • animal health and human health in relation to veterinary medicines, by increasing the availability of veterinary medicines and minimising the risks that may arise from the use of antimicrobials in veterinary medicine;
  • optimising the operation of the network, by ensuring that the right scientific expertise is available within the network to respond effectively to new public health challenges;
  • the global regulatory environment, by granting the network a strong international role including better oversight of global supply chains, contributing to global convergence of regulatory standards, promoting reliance and work-sharing with other regulators and strengthening capacity building.

EU medicines network strategy 2020 - key points

The strategy builds on the PDF iconEMA roadmap to 2015 and the HMA strategy 2011-15.

Separate multi-annual work programmes/implementation plans will be developed for EMA, HMA and the coordination groups for mutual recognition and decentralised procedures (CMDh and CMDv). These will give detailed information on the work of each component of the network and describe how the strategy will be taken forward.

Public consultation

The PDF icondraft strategy document was published for public consultation between March and June 2015. An overview of the public consultation outcome is available in the below documents:

Further information on the detailed comments received is provided in the below documents. Comments are listed by the number assigned to each stakeholder:

Road map 2010 – 2015

The Agency's Road map to 2015 set out the vision and priorities for the Agency for the period between 2010 and 2015:

The three priority areas outlined in the road map were:

  • addressing public health needs;
  • facilitating access to medicines;
  • optimising the safe and rational use of medicines.

The PDF iconimplementation plan of the road map, adopted in 2011, provides information on how the vision outlined in the road map had been developed gradually through its annual work programmes up to 2015.

Road map 2005 – 2010

In the Road map to 2010 the Agency set out its vision and priorities for the period between 2005 and 2010:

The three priority areas outlined in the road map were:

  • contributing to better protection and promotion of public and animal health;
  • improving the regulatory environment for medicinal products;
  • helping to stimulate innovation, research and development in the European Union.

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