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Joint strategy sets direction of EMA and EU medicines regulatory agencies to 2028
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.
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.
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