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EMA makes available guiding principles, reports, reflection papers and other documents on the use of AI in medicine regulation.
They aim to inform the pharmaceutical industry and to guide the European medicines regulatory network and academia on this topic.
For more information on EMA's work on AI, see:
A reflection paper on the use of artificial intelligence (AI) in the medicinal product lifecycle is available (linked below).
It includes considerations to help medicine developers and marketing authorisation applicants use AI and machine learning in a safe and effective way at the different stages of a medicine lifecycle.
The paper reflects EMA's experience in the evolving field of AI.
Medicine developers and applicants should understand the paper's considerations in the context of EU legal requirements and principles on AI, data protection, and medicines regulation.
EMA's Methodology Working Party developed the paper with support from the former Big Data Steering Group.
The Committee for Human Medicinal Products (CHMP) and the Committee for Veterinary Medicinal Products (CVMP) both adopted the paper in September 2024.
For more information, see:
EMA and the U.S. Food and Drug Administration (FDA) have jointly identified ten principles for good artificial intelligence (AI) practice in the medicines lifecycle.
The principles will guide AI use in evidence generation and monitoring across all phases of a medicine – from early research and clinical trials to manufacturing and safety monitoring.
They apply to both human and veterinary medicines.
AI observatory reports support the Network Data Steering Group (NDSG) to monitor AI activities and trends.
They also help the European medicines regulatory network build knowledge and prepare for future regulatory needs.
EMA and the Heads of Medicines Agencies (HMA) publish AI observatory reports every year.
The 2025 AI observatory report provides an overview of activities and trends focused on four broad areas:
EMA and HMA published the 2025 AI observatory report in June 2026.
AI observatory reports cover both human and veterinary medicines.
They inform the implementation of the NDSG workplan for 2026-2028 and the European medicines agencies network strategy (EMANS) to 2028.
For more information, see:
Select the expandable panel below for information about the 2024 AI observatory report:
The first annual report of the network's AI Observatory is available, including the results of a horizon scanning.
The report compiles the network's experience with artificial intelligence (AI) during 2024 in the following areas:
In addition to the report, two other related documents are also available:
The horizon scanning report is based on the review of scientific literature and EU-funded projects. It helps identifying gaps, challenges and opportunities for integrating AI in medicine regulation.
The observatory captures and shares experiences and trends in AI to inform the work of the Network Data Steering Group. It ultimately supports the implementation of the group's multi-annual AI workplan.
Guiding principles are available for network staff on how to use large language models (LLMs) in their work.
This document aims to promote the safe, responsible and effective use of this category of AI technology.
LLMs focus on text generation.
They can help staff at medicine regulators across the EU in areas such as:
However, LLMs also present challenges such as:
The overarching purpose of these guiding principles is to convey both capabilities and limitations of LLMs.
The document covers the following principles and recommendations on the use of large language models:
EMA and the Heads of Medicines Agency (HMA) published the first version of this document in September 2024. It is regularly updated.
Read guiding principles
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in November 2026.
11 November 2026
Page first published, containing information transferred from the AI hub page, including the 4 June 2026 update on the AI observatory report for 2025