Seizing opportunities in a changing medicines landscape
European medicines agencies network strategy to 2028 – launch of public consultation
NewsCorporateMedicines
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 few years.”
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 improves innovation and 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.
“The six focus areas have been carefully chosen to support the network’s core work of evaluating medicines as we take strides to promote the development of medicines and ensure that they reach those who need them.”
Input on the draft strategy is welcome from all stakeholders until 30 November 2024 via an online questionnaire.
EMA and the HMA will evaluate progress in each focus area by assessing how they achieve the goals set out in the strategy and will adapt their approaches as necessary to advances in science and technology, as well as to new opportunities that arise.
The updated strategy replaces the current network strategy to 2025 and incorporates the strategic aspects of EMA’s Regulatory Science Strategy. It takes into account progress made so far with the EMANS 2025 (as outlined in the mid-term report) and has been developed with input from experts from across the EU medicines regulatory network. More information on the drafting process and considerations driving the EMANS 2028 is included in a reflection paper, which is also published today to support the consultation on the draft strategy.
The draft strategy was endorsed by the HMA in September 2024 and by EMA’s Management Board at its 3 October 2024 meeting.
Following the eight-week public consultation, EMA and the HMA will finalise the strategy and it will be implemented via EMA’s and HMA’s respective multi-annual workplans.
EMA and HMA expect to adopt the final strategy by March 2025.