Collaboration on artificial intelligence

The European Medicines Agency (EMA) and the European medicines regulatory network are cooperating with European and international partners on the use of artificial intelligence (AI) in medicine regulation.
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EMA is collaborating with European and international partners to keep up with developments in the use of AI in medicine regulation.

This collaboration involves activities such as organising stakeholder workshops and analysing related use cases.  

To find more information on EMA's work to use AI in medicine regulation, see:

European Commission

EMA's AI-related work with with the European Commission includes:
 
  • Implementation of the AI Act
  • Preparation for the new pharmaceutical legislation
This collaboration aims to create a regulatory environment that supports innovation while ensuring safety, transparency, legal compliance and responsible AI use in medicines development and regulation.

EU Agencies Network

EMA chairs the EU Agencies Network's (EUAN) formal working group on artificial intelligence. 

The group brings together EU agencies and joint undertakings. Their main activities include:

  • Coordinating AI-related activities 
  • Sharing knowledge and best practices
  • Accelerating the responsible adoption of AI across EU agencies

Its main objectives:

  • Increasing AI maturity
  • Strengthening AI skills and competencies
  • Promoting collaboration on AI use cases and common initiatives
  • Ensuring effective coordination with EU institutions and stakeholders

It also supports common approaches to AI governance, AI literacy, AI use case assessments, and shared AI services across the EUAN.

EMA is chairing the group until 2027. As chair, EMA is responsible for activities such as:

  • Organising plenary meetings and workshops
  • Engaging with EU institutions and bodies, including the EU AI Office and European Data Protection Supervisor (EPDS) on AI-related matters
  • Building AI capabilities and fostering consistent AI adoption across EU agencies

For more information, see:

Heads of Medicines Agencies

EMA collaborates with the Heads of Medicines Agencies (HMA), via the network, to coordinate activities on the use of AI in medicines regulation. This is part of the Network Data Steering Group (NDSG)'s workplan for 2026-2028.

EMA and the HMA established a dedicated AI-focused stakeholder group with pharmaceutical, veterinary and medical-device industry associations. This group provides a forum to discuss topics such as AI use cases and opportunities for responsible innovation. It also helpis regulators understand emerging industry practices.

In addition, EMA and HMA convene regular AI workshops bringing together regulators, industry, academia, patients and experts. These events host discussions on aspects like AI policy developments and regulatory activities.

For more information, see:

International Coalition of Medicines Regulatory Authorities

EMA participates in the International Coalition of Medicines Regulatory Authorities (ICMRA)'s activities related to AI.

It does so to facilitate knowledge-sharing and discussion among medicines regulators worldwide.

This collaboration supports global regulatory cooperation and alignment on emerging AI-related topics affecting medicines regulation.

For more information, see:

US Food and Drug Administration

EMA and US Food and Drug Administration (FDA) co-developed guiding principles for good AI practice in medicine development.

These principles are meant to:

  • Support safe, ethical and scientifically robust use of AI throughout the medicine lifecycle
  • Promote regulatory convergence
  • Enable future guidance development
  • Strengthen international cooperation on AI-enabled medicines regulation

To read the guiding principles and learn more about the EMA-FDA collaboration on AI, see:

AI research community

EMA contributes to regulatory science activities and publications on AI.
 
This includes defining AI research priorities and monitoring related developments through deliverables like the EMA's AI Observatory.
 
This contribution is meant to:
 
  • Identify evidence gaps
  • Support trustworthy innovation
  • Guide future regulatory approaches for AI in medicines
For more information, see:
 

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The tracking of updates begins in November 2026.

11 November 2026

Page first published

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