Strategy Papers

EU Medicines Agencies Network Strategy to 2025

EMA and the Heads of Medicines Agencies (HMA) have published their joint strategy to 2025, following its adoption by the HMA and EMA Management Board.

The strategy details how the European medicines regulatory network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.

The European medicines agencies network strategy to 2025 outlines six priority areas for the network:

  •     the availability and accessibility of medicines;
  •     data analytics, digital tools and digital transformation;
  •     innovation;
  •     antimicrobial resistance and other emerging health threats;
  •     supply chain challenges; and
  •     the sustainability of the network and operational excellence.

It identifies strategic goals for each of these areas, which will be translated into concrete actions in the detailed work plans of EMA and the national competent authorities in EU Member States in the coming five years. It also considers some of the recent developments related to the COVID-19 pandemic. Further learnings from the pandemic have been incorporated into the strategy and will be taken into account in subsequent work plans on an ongoing basis.

The joint EMA//HMA strategy was open for public consultation from July to September 2020. The extensive and helpful feedback from the public consultation, which captured input from a full range of stakeholder groups, was carefully analysed and reviewed in order to refine and finalise the strategy. More detail on the comments received and the network’s analysis of these comments is available in a separate document.

The European medicines agencies network strategy was developed in consultation with the European Commission and the key themes are aligned with those covered in the Commission’s Pharmaceutical Strategy that will set the tone of future pharmaceutical policy for human medicines in the EU.

The network will review the strategy after 18 months to consider if the goals and objectives remain appropriate, and to adjust them if necessary, in the light of the changing environment and ongoing engagement with stakeholders.

EU Medicines Agencies Network Strategy to 2025 | pdf


EU Medicines Agencies Network Strategy to 2020

The European Medicines Agency (EMA) Management Board and the Heads of Medicines Agencies (HMA) have adopted a common strategy to 2020 for the European medicines regulatory network.

This is the first time that a single strategy for the whole network has been developed. It outlines common challenges and opportunities and sets out joint key priorities and a high-level roadmap to achieve these over the next five years. The strategy also supports the strategic priorities of the European Commission and the European Union (EU) agenda on human and animal health.

EU Medicines Agencies Network Strategy to 2020 | pdf

Multi Annual Work Plan

After finalisation of the joint HMA/EMA strategy to 2020, the HMA developed a Multi Annual Work Plan (MAWP) to bring the joint overarching strategy into operation on the HMA level with the involvement of all National Competent Authorities. The MAWP has been developed by a HMA taskforce and was debated extensively in break-out sessions during the 2015 HMA plenary meetings in Luxemburg and Dubrovnik. The MAWP has been adopted on 17 February 2016 during the 83rd HMA meeting in Amsterdam.

Eleven topics were agreed as priority areas, namely:

  • Antimicrobial resistance
  • Availability of good quality appropriately authorised medicines
  • Competence development programme through the EU Network Training Centre
  • Developing an efficient, effective and collaborative approach on inspections to address sustainability
  • Innovation and access to new medicines
  • International collaboration
  • Optimisation of the regulatory operations
  • Responding to public and animal health emergencies
  • Strengthen surveillance
  • Implementation of the Telematics strategy
  • Support for better use of medicine

Multi Annual Work Plan (MAWP) | pdf

HMA Strategy Paper (2010)

The European Heads of Medicines Agencies (HMA) group devloped a second HMA strategy document for the period 2011-2015, which was finalised and published at the end of 2010. As part of the strategy developemnt process, and in line with good practice, the HMA consulted with key stakeholder groups on the strategy's content.

HMA Strategy Paper 2010 | pdf