Seizing opportunities in a changing medicines landscape

EMA and the Heads of Medicines Agencies (HMA) have published their draft joint EU network strategy to 2028 for an eight-week public consultation. This is a review and update to the original five-year strategy, which was developed to cover the period 2021 to 2025 (EMANS 2025). Since then, several changes to the regulatory and technological landscape have occurred, some more rapidly than anticipated. For example, the European Union has enacted new legislation to handle public health emergencies and established the Directorate-General for Health Emergency Preparedness and Response (DG HERA) to improve the EU’s crises preparedness. Technological advances, particularly in artificial intelligence, have presented opportunities to transform the way medicines are developed and regulated across the network. Furthermore, the EU has made steps to revise its pharmaceutical legislation in the largest reform of the EU medicines regulation in decades. These changes made it necessary to update the EMANS 2025 and to seize the opportunities that they present. “The overarching theme of our updated strategy to 2028 is that of change – rapid, somewhat unpredictable but nonetheless full of promise. It will guide the network as it seizes opportunities and meets the challenges of the near future, including preparing for and responding to public health emergencies and threats such as antimicrobial resistance. Now is the time to share your views and help shape the direction of the network for the next...