An artificial intelligence (AI) workplan for the European medicines regulatory network is available to guide the use of AI in medicines regulation in Europe to 2028.
It identifies actions for regulators in four key areas:
- Guidance, policy and product support - delivering guidance on the use of AI throughout the medicine lifecycle
- AI tools and technology - providing frameworks for the use of AI tools
- Collaboration and training - developing capacity for the use of AI technology
- Experimentation - ensuring a structured and coordinated approach
The Big Data Steering Group developed the AI workplan. It was endorsed by the Heads of Medicines Agencies (HMA) in November 2023, and by the European Medicines Agency's (EMA) Management Board in December 2023.
The steering group maintains this workplan over time.
For more information, see:
AI in medicinal product lifecycle reflection paper
A reflection paper on the use of artificial intelligence (AI) in the medicinal product lifecycle is available:
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.
This paper reflects EMA's current 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.
The Methodology Working party developed the paper with support from the 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.
Large language model guiding principles
Guiding principles are available for European medicines regulatory network staff on how to use large language models in their work.
This document aims to promote the safe, responsible and effective use of this category of artificial intelligence (AI) technology.
Large language models focus on text generation.
They can help staff at medicine regulators across the EU in areas such as processing extensive documentation, automating data mining and optimising routine administrative tasks.
They also present challenges such as providing irrelevant or inaccurate responses and posing potential data security risks.
The overarching purpose of these guiding principles is to convey both capabilities and limitations of large language models.
Guiding principles
The document covers the following principles and recommendations on the use of large language models:
- Ensuring safe input of data;
- Applying critical thinking and cross-checking outputs;
- Upholding continuous learning;
- Knowing whom to consult when concerns arise.
EMA and HMA published the first version of this document on September 2024. It is regularly updated.
Read guiding principles

Factsheet: Four principles for safe and responsible use of large language models
AI tools and technology
In March 2024, EMA introduced an AI-enabled knowledge mining tool called Scientific Explorer for EU regulators.
The tool enables easy, focused and precise search of regulatory scientific information from network's sources to support decision-making and simplify processes.
The first releases focuses on scientific advice procedures for human medicines and veterinary medicines.
For more information, see the document below with answers to frequently asked questions about the tool:
Public consultation on draft qualification opinion of AI model
A draft qualification opinion for artificial intelligence used to determine disease activity in liver biopsies is available for public consultation.
EMA's Scientific Advice Working Party and CHMP invite comments from stakeholders knowledgeable of clinical studies of metabolic dysfunction-associated steatohepatitis.
They also invite comments from stakeholders with experience of using artificial intelligence to generate clinical evidence.
The deadline to provide your feedback is 25 January 2025.
Submit your comments to ScientificAdvice@ema.europa.eu using the template below: