European medicines agencies network strategy

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) identify shared challenges, goals and priorities in five-year strategy documents, to give strategic direction to the work of the European medicines regulatory network

Guided by this strategic approach, the network aims to collectively tackle current and future challenges more effectively. 

Draft network strategy to 2025

The draft network strategy to 2025 sets out how the European medicines regulatory network intends to continue enabling the supply of safe and effective medicines in the face of developments in science, medicine, digital technologies, globalisation and emerging health threats.

The draft strategy was open for public consultation until 4 September 2020:

The draft strategy outlines six priority areas in line with the European Commission's roadmap for a Pharmaceutical strategy for Europe

  • Availability and accessibility of medicines
  • Data analytics, digital tools and digital transformation
  • Innovation
  • Antimicrobial resistance and other emerging health threats
  • Supply-chain challenges
  • Sustainability of the network and operational excellence

The strategy's high-level goals and supporting recommendations serve to guide the development of detailed separate work plans by EMA and the national competent authorities in European Union (EU) Member States for the coming five years, from 2021 to 2025. 

Recent developments linked to the COVID-19 pandemic fed into the strategy's development. Further lessons from the pandemic will continue to inform future reviews of the strategy and of subsequent work plans.  

Development of the strategy also took account of early consultative input from patient, consumer and healthcare-professional organisations, and from industry, academia and veterinary stakeholders.

EMA's Management Board and HMA intend to adopt the final document towards the end of 2020, after considering responses to the public consultation. 

Network strategy to 2020

The network strategy for 2016 to 2020 focuses on strategic priority areas where the network can make a difference to human and animal health in the EU:

The stategy 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.

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

The PDF icondraft strategy document was open for public consultation between March and June 2015.

Previous road maps

The Agency's Road map to 2015 set out the vision and priorities for the Agency for 2011 to 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.

In its road map to 2010 the Agency set out its vision and priorities for 2006 to 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.

Topics

How useful was this page?

Add your rating
Average
2 ratings