EMA publishes EU strategy to 2028

A draft joint EU network strategy to 2028 has been published by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA).

This is updated strategy replaces the original five-year strategy, which was developed to cover from 2021 to 2025 (EMANS 2025).

Revised strategy – adapting to change

The draft strategy covers the following focus areas up to 2028:

• Accessibility to support pathways for medicine access in the EU
• Leveraging data, digitalisation and artificial intelligence (AI)
• Create a regulatory and research environment that improves innovation and competitiveness in EU healthcare
• Prepare the EU for potential threats such as antimicrobial resistance (AMR)
• Strengthen EU medicine supply
• Ensure that the network has available resources to support its scientific and regulatory decision making.

The EMA highlighted that advances in technology such as artificial intelligence (AI) has created opportunities to transform medicine development and regulation. Changes have occurred “more rapidly than anticipated”, prompting revision of the original strategy, according to the EMA.

Examples of these changes include enactment of the Directorate-General for Health Emergency Preparedness and Response (DG HERA) to improve the EU’s crises preparedness, as well as revision of the pharmaceutical legislation as the biggest EU medicines regulation reform in decades, EMA explained.

“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,” explained Emer Cooke, EMA Executive Director.

The final strategy is anticipated to be adopted by March 2025, according to EMA and HMA.

Feedback on the draft strategy can be submitted online here until 30 November 2024.