EU regulators propose updated medicines strategy to include AI growth, new pharma legislation

The European Medicines Agency (EMA) and EU Heads of Medicines Agencies (HMA) have proposed an updated strategy for fostering the development and supply of drugs in the region over the next several years. The agency said that advancements in areas such as artificial intelligence (AI) and new legislative developments have led it to reconsider some aspects of its current five-year strategy.

During the early days of the COVID-19 pandemic, the European medicines agencies network, including EMA and the national competent authorities (NCA), developed a five-year strategy to promote new drugs reaching the European market entitled the European medicines agencies network strategy to 2025 (EMANS 2025). It laid out steps regulators planned to take through 2025 to achieve their goals. However, EMA realized that a lot has changed since the strategy was developed, leading regulators to reconsider those goals and to update the strategy through 2028.

EMA said several significant changes have happened since it developed EMANS 2025 was adopted, including the Directorate-General Health Emergency Preparedness and Response (DG HERA), which was created to prepare Europe for future pandemics following lessons learned from COVID-19. The agency also noted that several technological advances have moved faster than anticipated, in particular AI technology, and the EU has taken steps to revise its pharmaceutical legislation, which it said will be the largest reform for the sector in decades.

“These and other changes herald a brighter future for EU medicines regulation, and it was necessary to review and update EMANS 2025 if we are to seize the opportunities they present,” said EMA. “While EMANS 2028 cannot pre-empt the legislative changes or predict the future, this strategy will prepare the network for the revisions to the pharmaceutical legislation and further changes to the technological and regulatory landscape.”

“EMANS 2028 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,” the agency added.

The theme of EMANS 2028 hasn’t changed and is focused on anticipated changes that will drive six focus areas, including accessibility to drugs; leveraging data, digitization and artificial intelligence; regulatory science, innovation and competitiveness; antimicrobial resistance and other health threats; availability and supply; and sustainability of the European medicines agencies network.

Alongside the draft EMANS 2028 proposal, EMA also published a reflection paper detailing how it decided to update its strategy. Stakeholders can comment on the draft EMANS 2028 document until 30 November through the EMA’s website.

The document is expected to be finalized by March 2025, and then the heads of medicines agencies (HMA) and EMA's management board must sign off on the final version. The final version of EMANS 2028 is expected to be adopted and published by the beginning of the second quarter of 2025.

Draft EMANS 2028
EMA reflection paper

EU regulators propose updated medicines strategy to include AI growth, new pharma legislation

Related topics

Recommended content

Welcome to the new RAPS Digital Experience