EMA and HMA Publish Joint Network Strategy to 2028

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of heads of regulatory authorities that are responsible for regulating human and veterinary medicines in the European Economic Area, have published their joint European Union (EU) medicines agencies’ network strategy (EMANS) to 2028, “Seizing Opportunities in a Changing Medicines Landscape,” which EMA said both its management board and HMA have adopted (1).

“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,” Emer Cooke, EMA executive director, said in a press release (1). “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 (AI), require a significant update to our network strategy so that we can seize the opportunities that they present.”

EMANS 2028 is described by EMA as a comprehensive update of EMANS 2025, which was developed to cover the years 2021 to 2025 and has six focus areas, introducing what EMA and HMA call the “One Health Approach”:

• accessibility (facilitating pathways to medicines access through the EU’s healthcare systems)

• leveraging data, digitalization, and AI (with the end goals of improved decision-making, optimized processes, and increased efficiency)
• regulatory science, innovation, and competitiveness (to create a research environment that accelerates the translation of innovation)
• antimicrobial resistance and other health threats
• availability and supply (for both humans and animals)
• sustainability of the network, taking advantage of technological advances (1).

“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,” Maria Lamas, chair of HMA Management Group, said in the release (1). “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 catalyze the innovation of medicines and their manufacture by leveraging every opportunity to promote public and animal health.”

EMA and HMA first announced that EMANS 2028 was open for public consultation in October 2024, a period which ended Nov. 30, 2024 (2). At the time, EMA said that new regulations (e.g., legislation to address public health emergencies and reform of the EU medicines regulations) and technical advances, such as the use of AI, were some of the main drivers for the changes to the original strategy.

The 2021–2025 EMANS was published in December 2020, and a midterm report that examined its achievements from January 2021 to June 2023 found that the COVID-19 pandemic, which was still in its first year at the beginning of that timeframe, strengthened the network, allowing it to be on track to meet its goals and objectives regarding drug availability, data management, innovation, antimicrobial resistance, supply chain challenges, and sustainability of the network (3). EMA said that EMANS 2028, prepared in a post-pandemic setting, draws on extensive experience gained in the EU from responding to COVID-19 (1).

The final, adopted version of EMANS 2028 is available via PDF download at this link.

References

1. EMA. Joint Strategy Sets Direction of EMA and EU Medicines Regulatory Agencies to 2028. Press Release. March 18, 2025.
2. EMA. Seizing Opportunities in a Changing Medicines Landscape. Press Release. Oct. 9, 2024.
3. EMA. Midterm Report on 2025 Network Strategy Highlights Good Progress During Critical Period of the Pandemic. Press Release. Dec. 20, 2023.