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. 

Network strategy to 2028

The European medicines agencies network strategy to 2028 is available below. 

The strategy equips the European medicines regulatory network to respond to change and address challenges such as public health emergencies and threats, including antimicrobial resistance.

It focuses on six areas:

• Accessibility - facilitating access to medicines in the EU
• Leveraging data, digitalisation and artificial intelligence - improving decision-making, optimising processes and increasing efficiency
• Regulatory science, innovation and competitiveness - helping improve innovation and competitiveness in the EU healthcare sector
• Antimicrobial resistance and other health threats - preparing the EU for potential threats including antimicrobial resistance
• Availability and supply - strengthening availability of medicines to protect public and animal health
• Sustainability of the European medicines agencies network - ensuring available resources to support its scientific and regulatory decision-making

The updated network strategy to 2028 builds on the strategy to 2025. 

It places greater emphasis on the competitiveness of the EU in developing and manufacturing medicines, ensuring they are accessible and available to EU citizens while leveraging artificial intelligence. 

It also highlights the One Health approach, recognising that the health of humans, animals and the wider environment are closely linked. 

EMA and the Heads of Medicines Agencies (HMA) adopted the final strategy in March 2025.

They also published a summary of the public consultation results. This public consultation took place between October and November 2024.

In addition, a reflection paper that informed the draft strategy is also available for reference.

Seizing opportunities in a changing medicines landscape: The European medicines agencies network strategy 2028 (final)

Analysis and summaries of public consultation results: The European medicines agencies network strategy to 2028

Reference Number: EMA/98153/2025

Towards the European medicines agencies network strategy 2028: Reflection paper

Reference Number: EMA/297150/2024

Seizing opportunities in a changing medicines landscape: The European medicines agencies network strategy 2028 (draft)

Draft: consultation closed Consultation dates: 09/10/2024 to 30/11/2024 Reference Number: EMA/376542/2024

For more information, see: 

• Antimicrobial resistance
• Public health threats
• Artificial intelligence

Previous network strategies and roadmaps

Network strategy to 2025

The European medicines agencies network strategy to 2025 guided the network in continuing to enable the supply of safe and effective medicines. 

It took into consideration developments in science, medicine, digital technologies, globalisation and emerging health threats, such as the COVID-19 pandemic:

European Union Medicines Agencies Network Strategy to 2025 - Protecting public health at a time of rapid change

The strategy outlined six priority focus 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

A midterm report published in December 2023 found that the COVID-19 pandemic strengthened the network and brought about transformative change in the European system across key strategic areas:

European medicines agencies network strategy to 2025: Mid-point report to Q2 2023

EMA and the HMA published the strategy in December 2020, following its adoption by the HMA and EMA's Management Board.

It was developed via a two-month public consultation. It received early input from stakeholders such as patient, consumer and healthcare-professional organisations, and from industry, academia and veterinary representatives:

Analysis and summaries of public consultation results - European Medicines Agencies Network Strategy to 2025

Network strategy to 2020

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

EU Medicines Agencies Network Strategy to 2020: Working together to improve health

Adopted Reference Number: EMA/MB/151414/2015

The strategy was 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 roadmap to 2015 and the HMA strategy 2011-15.

Road map to 2015: The European Medicines Agency’s contribution to science, medicines and health

Adopted Reference Number: EMA/299895/2009

The EU medicines agencies strategy to 2020 was open for public consultation between March and June 2015.

For more information, see:

EMA medicines agencies network strategy to 2020 - related documents

Outcome of the public consultation on the EU Medicines Agencies Network Strategy to 2020

Reference Number: EMA/667824/2015

Extract from the published minutes of the EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: Annex 1

Reference Number: EMA/670072/2015

EU Medicines Agencies Network Strategy to 2020: Summary report of the meeting with Industry Stakeholders Associations for human medicines 23 June 2015: Annex 2

Reference Number: EMA/441188/2015

EU Medicines Agencies Network Strategy to 2020 : Comments received from public consultation - List of stakeholders

Reference Number: EMA/464136/2015

Overview of comments received on “EU Medicines Agencies Network Strategy to 2020”

Reference Number: EMA/848469/2015

Roadmap to 2015

EMA's roadmap to 2015 set out the vision and priorities for the Agency for 2011 to 2015:

Road map to 2015: The European Medicines Agency’s contribution to science, medicines and health

Adopted Reference Number: EMA/299895/2009

The three priority areas outlined in the roadmap were:

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

For information on how the outlined in the 2015 roadmap was been developed, see: 

Implementing the European Medicines Agency’s road map to 2015: The Agency's contribution to science, medicines, health

Adopted Reference Number: EMA/MB/550544/2011 Summary:

The European Medicines Agency’s Road map to 2015 sets out the Agency’s vision, elaborates on the

main drivers for progress and change that will impact on it, and explores the main initiatives to be

undertaken to successfully meet the challenges it will face. It encompasses the Agency’s strategy for

both medicines for human and veterinary use in line with the joint responsibility of the Agency.1 This

implementation plan provides information on how the vision outlined in the Road map to 2015 is

expected to be developed.

Roadmap to 2010

EMA's roadmap to 2010 set out its vision and priorities for 2006 to 2010.

The European Medicines Agency road map to 2010: Preparing the ground for the future

Reference Number: EMEA/H/34163/03/Final

The three priority areas outlined in the roadmap 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.