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 2025

The European medicines agencies network strategy to 2025 (also referred to as the 'network strategy') sets out how the network will continue to enable the supply of safe and effective medicines, in the face of 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

A midterm report is available, which found that the COVID-19 pandemic strengthened the network and supported transformative change in the European system across key strategic areas:

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

The strategy outlines 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

The document identifies strategic goals and objectives for each of these areas, which EMA and the HMA will translate into concrete actions in their detailed work plans.

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

Development of the strategy took account of early consultative input from patient, consumer and healthcare-professional organisations, and from industry, academia and veterinary stakeholders, as well as stakeholder feedback received through a two-month public consultation on the network strategy to 2025:

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

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

Previous network strategy and roadmaps

Network strategy (2016 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

AdoptedReference 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

AdoptedReference Number: EMA/299895/2009

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

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

AdoptedReference Number: EMA/MB/151414/2015

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 (2011 to 2015)

The Agency'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

AdoptedReference Number: EMA/299895/2009

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.

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

AdoptedReference Number: EMA/MB/550544/2011Summary:

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 (2006 to 2010)

In its roadmap to 2010 the Agency 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 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.