Amsterdam, 18 March 2025
EMA and the Heads of Medicines Agencies (HMA) have published their joint EU medicines agencies’ network strategy to 2028 (EMANS), following its recent adoption by the HMA and the EMA Management Board.
The strategy, titled ‘Seizing opportunities in a changing medicines landscape’, is a comprehensive update of the five-year strategy which was developed to cover the period 2021 to 2025 (EMANS 2025). The updated document will guide the European medicines regulatory network over the next few years to meet the challenges ahead, including preparing for, and responding to, public health emergencies and threats such as antimicrobial resistance.
“I am delighted to present our joint EMA / HMA network strategy to 2028. With new legislation on the horizon, we are preparing for the most significant regulatory reform in decades. In these uncertain times, when our environment is evolving constantly, we need to be agile and to be able to anticipate transformative changes, as well as to better address supply chain security. Innovations in the development of medicines, including the use of artificial intelligence, require a significant update to our network strategy so that we can seize the opportunities that they present.”
Emer Cooke, EMA’s Executive Director
The six focus areas of the strategy to 2028 build upon those in the EMANS to 2025 with the updated strategy placing more emphasis on the competitiveness of the EU in the development and manufacture of medicines, as well as the use of artificial intelligence throughout the medicines’ lifecycle. The ‘One Health Approach’ is introduced as a key aspect of the strategy, recognising that the health of humans, animals and the wider environment are closely intertwined.
Prepared in a post-pandemic setting, the strategy draws on the extensive experience gained from tackling COVID-19. It also takes into account the ongoing revision of the EU’s pharmaceutical legislation, laying the groundwork for its implementation.
Ultimately, this strategy will support the network’s core work of evaluating and promoting the development of safe and effective medicines and ensuring they reach those who need them.
“With the strategy to 2028, our aim is to ensure a transparent, forward-looking and science-driven roadmap to managing the network’s public health priorities. In the face of a new global framework, it is important that the European medicines regulatory agencies contribute to EU competitiveness. We are committed to catalyse the innovation of medicines and their manufacture by leveraging every opportunity to promote public and animal health.”
Maria Lamas, chair of HMA Management Group
The six strategic focus areas of EMANS to 2028
The strategic focus areas of the strategy to 2028 are as follows:
- Accessibility – to facilitate pathways for access to medicines through healthcare systems in the EU.
- Leveraging data, digitalisation and artificial intelligence – to improve decision-making, optimise processes and increase efficiency.
- Regulatory science, innovation and competitiveness – to create a regulatory and research environment that accelerates the translation of innovation and improves competitiveness of the EU’s healthcare sector.
- Antimicrobial resistance and other health threats – to prepare the EU for potential threats including antimicrobial resistance.
- Availability and supply – to strengthen the availability of medicines to protect public and animal health.
- Sustainability of the network – to ensure that the network has available resources to support its scientific and regulatory decision-making, taking full advantage of technological advances.
The strategy was developed through extensive collaboration with experts and stakeholders across the EU medicines regulatory network. A public consultation took place in late 2024, during which 77 submissions from the public and stakeholders provided valuable feedback which helped shape the strategy. EMA and the HMA, in partnership with the EU Polish presidency, also held a webinar with stakeholders in February 2025 to further refine and finalise the text.
EMA and HMA will now implement the strategy via their respective multi-annual workplans and at national level. The network will monitor its implementation, report back and adjust as needed.
The final strategy is published with an overview of the comments received during the public consultation.
Related documents
- Seizing opportunities in a changing medicines landscape: The European medicines agencies network strategy 2028 (final) – 18 March 2025 – View
- Analysis and summaries of public consultation results: The European medicines agencies network strategy to 2028 – View
Related content
- European medicines agencies network strategy
- One Health approach
- Antimicrobial resistance
- Artificial intelligence
- Coronavirus disease (COVID-19)
- Management Board
External links
Source – EMA