Artificial intelligence

The European Medicines Agency (EMA) is helping integrate artificial intelligence (AI) in medicine regulation by releasing tools, providing guidance, upholding principles of use, strengthening governance and collaborating with partners.

EMA and other regulators within the European medicines regulatory network are using AI to enhance their efficiency and performance. They are developing and rolling out tools to assist with key activities, such as:

• Knowledge-mining on regulatory processes
• Personal productivity
• Automation of processes and systems
• Data analysis to inform decision-making regarding medicines

In parallel, EMA is providing guidance on the use of AI in medicine regulation, focusing on aspects like:

• Safety, responsibility and effectiveness in the use of large-language models
• Use of AI in evidence generation and monitoring

EMA is also developing and upholding governance and principles for how it uses AI, which ensures clarity, transparency and predictability. This is in line with the EU AI Act.

In addition, EMA is collaborating with European and international partners to keep up with this fast-moving area.

EMA's work on AI is helping equip the network to implement the EU's new pharmaceutical legislation, in particular in areas such as support to innovation.

For more information on the use of AI and data in medicine regulation, see:

• Data in regulation: Big data and other sources

In this section

Tools and technology

Tools that EMA develops and uses to help transition to medicine regulation processes enabled by AI

Guidance

Guidance helping stakeholders in medicine development and regulation adapt to and use AI safely and effectively

Principles and rules

How EMA staff uses AI tools and technology

Governance and policies

EMA governance and policies to help guide the use of AI in medicine regulation

Collaboration

AI-related initiatives in collaboration with European and international partners

From concept to practice

Using AI in medicine regulation for outcomes such as developing higher-quality medicines more quickly

New pharmaceutical legislation

Information on the changes introduced by the EU's comprehensive overhaul of its pharmaceutical legislation.

Learn about new pharmaceutical legislation

Image credit: © Marcos Osorio/Stocksy | stock.adobe.com

Data in medicine regulation

EMA uses different types of data to support its decisions on the safety, efficacy, and quality of medicines.

Learn about data in regulation

Page update history

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 March 2026.

See update history

11 November 

Page reorganised as a hub for AI-related content on this website, linking to subpages with specific information on areas such as AI guidance, tools and governance

14 August 2026

'Related scientific publications' section updated to highlight the article on 'Regulatory Research Priorities for AI Use in the Medicine Lifecycle: A European Perspective with Global Relevance'

4 June 2026 

'AI Observatory reports' section updated to include information on the AI observatory report for 2025

3 March 2026

'AI tools and technology' section updated with information on the extended functionality of EMA's AI-enabled knowledge mining tool Scientific Explorer. The extended functionality helps national competent authorities search for initial marketing authorisation applications.