EMA and Heads of Medicines Agencies strategy to 2028 prioritizes competitiveness, data, and AI in medicines

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have officially adopted the European Medicines Agencies Network Strategy to 2028 (EMANS 2028), setting out priorities to boost the EU’s global competitiveness in medicine development and manufacturing.

Adopted in March 2025, EMANS 2028 sets out a roadmap to strengthen regulation and improve patient access to medicines across Europe. The strategy, titled “Seizing opportunities in a changing medicines landscape”, reflects the need for agility in responding to evolving technologies, health threats, and supply chain challenges.

Building on lessons from the COVID-19 pandemic and anticipating upcoming pharmaceutical legislation reforms, EMANS 2028 places strong emphasis on integrating digital technologies, data-driven approaches, and AI to support regulatory decision-making and foster innovation in the EU medicines sector.

EMANS 2028 also highlights the One Health approach, recognizing that the health of humans, animals, and the wider environment are closely linked. It places renewed emphasis on ensuring medicines are both accessible and available while positioning the EU as a leader in innovation and biomanufacturing.

“With new legislation on the horizon, we are preparing for the most significant regulatory reform in decades,” said EMA Executive Director Emer Cooke. “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.”

The strategy outlines six strategic focus areas: accessibility, leveraging data and AI, regulatory science and competitiveness, antimicrobial resistance (AMR) and health threats, availability and supply, and sustainability of the network, as previously explored in this article on key highlights and public reactions. “Our aim is to ensure a transparent, forward-looking and science-driven roadmap to managing the network's public health priorities,” added Maria Lamas, Chair of the HMA Management Group.

EMANS 2028 incorporates significant changes based on feedback from a public consultation held between October and November 2024, which gathered 77 responses from patient groups, healthcare professionals, researchers, public bodies, and industry. A summary of the consultation results was published alongside the final strategy. The feedback led to enhanced emphasis on the One Health approach, greater recognition of cross-sectoral legislative impacts, and a strengthened focus on competitiveness and the use of AI.

Following the consultation, the strategy was revised to clarify the roles of regulators and health technology assessment (HTA) bodies in improving accessibility to both innovative and off-patent medicines. ‘Theme 2: Leveraging Data, Digitalization, and AI’ was updated to reinforce commitments to data protection and cybersecurity, explicitly reference the European Health Data Space (EHDS), and incorporate systems like the Product Management Service (PMS) and electronic product information (ePI).

Theme 3 saw updates supporting biomanufacturing competitiveness, integrating real-world data, and encouraging non-animal testing methods. Proposals also called for new regulatory tools and better stakeholder communication. Other changes included references to marketing authorization terms in AMR strategies, balanced communication on medicine shortages, and integrating environmental sustainability into the network’s operations.

However, not all feedback resulted in changes. Some suggestions, particularly under Theme 2, were considered beyond the scope of the strategy but will inform implementation. These included calls to broaden EHDS implementation beyond regulator remits, expand its rollout at the national level first, and provide detailed references to technical systems such as the Identification of Medicinal Products (IDMP), Fast Healthcare Interoperability Resources (FHIR), and EMA’s IRIS platform. Concerns were also raised about safeguarding evidence standards, data limitations, intellectual property protection, and maintaining applicant responsibility for data and evidence generation.

EMA and HMA emphasized that EMANS 2028 is a high-level framework, with specific actions, timelines, and measurable outcomes detailed in the agencies’ multi-annual work plans.

“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,” Cooke noted.

Stakeholders broadly welcomed the strategy, with many acknowledging that successful implementation could improve timely access to medicines across Europe. EMA and HMA will monitor progress, report back, and adjust the strategy as needed to ensure accountability.