Europe: EMA publishes its own Artificial Intelligence Medicines workplan

27 Dec 2023    2 minute read
Sectors Healthcare & Life Sciences
Healthcare & Life Science Medicinal Products European Medicines Agency Artificial Intelligence AI

In brief

The European Medicines Agency (EMA) has published an artificial intelligence workplan to 2028, setting out new strategy on its use. The aim of this workplan is to benefit public health through boosting the opportunities of artificial intelligence in different health fields.

Contents

In more detail

On 18 December 2023, the EMA published a workplan on Artificial Intelligence (AI) that includes a multitude of actions between 2023 and 2028. In this sense, the aim is to have a collaborative strategy to maximize the benefits of AI without falling into the risks that its use entails.

Taking into account the implications of AI in different areas of the healthcare sector, the EMA has focused its efforts on four dimensions that should contribute to improving the understanding and use of AI in a responsible way. The proposed workplan will be subject to future modifications as this technology evolves.

The key dimensions of the EMA workplan can be summarized as follows:

  • Guidance, policy and product support: It aims to support the development of AI in the life cycle of medicinal products. In this regard, it is envisaged that guidance and orientations will be approved in areas such as pharmacovigilance or the use of large language models. Moreover, preparations for the entry into force of the AI Law and the creation of an observatory to monitor it are foreseen for the second half of 2024.
  • AI tools and technology: Multiple objectives are envisaged for 2024, including ensuring compliance with data protection regulations; implementing guidance to support communication through generative AI together with the implementation of language models as assistants. In addition, a survey and the publication of a policy on the capabilities of Network Tools are also foreseen.
  • Collaboration and training: During 2024, it is foreseen to enhance collaboration on AI understanding and application by, among other measures, working with international partners specialized in AI, the creation of the AI Special Interest Area and the creation of an extended platform for the Digital Academy on AI and data analytics.
  • Experimentation: Multiple experimentation cycles, guided by technical deep dives, are foreseen between 2024 and 2027, along with the definition of guiding principles for the responsible use of AI. Furthermore, the network's research priorities will also be defined.

Through this workplan, the EMA takes a solid step forward in terms of integrating AI into its procedures and into the life cycle of medicinal products, which will undoubtedly be a milestone in terms of data collection and decision-making that may affect human health.

For more information, please click on this link to read the full IA workplan of the EMA. In case you need individual advice for your company, please contact our team of experts in this field.

Contact Information
Montserrat Llopart
Partner
Barcelona
Read my Bio
montserrat.llopart@bakermckenzie.com
David Molina
Associate
Barcelona
david.molina@bakermckenzie.com

Copyright © 2025 Baker & McKenzie. All rights reserved. Ownership: This documentation and content (Content) is a proprietary resource owned exclusively by Baker McKenzie (meaning Baker & McKenzie International and its member firms). The Content is protected under international copyright conventions. Use of this Content does not of itself create a contractual relationship, nor any attorney/client relationship, between Baker McKenzie and any person. Non-reliance and exclusion: All Content is for informational purposes only and may not reflect the most current legal and regulatory developments. All summaries of the laws, regulations and practice are subject to change. The Content is not offered as legal or professional advice for any specific matter. It is not intended to be a substitute for reference to (and compliance with) the detailed provisions of applicable laws, rules, regulations or forms. Legal advice should always be sought before taking any action or refraining from taking any action based on any Content. Baker McKenzie and the editors and the contributing authors do not guarantee the accuracy of the Content and expressly disclaim any and all liability to any person in respect of the consequences of anything done or permitted to be done or omitted to be done wholly or partly in reliance upon the whole or any part of the Content. The Content may contain links to external websites and external websites may link to the Content. Baker McKenzie is not responsible for the content or operation of any such external sites and disclaims all liability, howsoever occurring, in respect of the content or operation of any such external websites. Attorney Advertising: This Content may qualify as “Attorney Advertising” requiring notice in some jurisdictions. To the extent that this Content may qualify as Attorney Advertising, PRIOR RESULTS DO NOT GUARANTEE A SIMILAR OUTCOME. Reproduction: Reproduction of reasonable portions of the Content is permitted provided that (i) such reproductions are made available free of charge and for non-commercial purposes, (ii) such reproductions are properly attributed to Baker McKenzie, (iii) the portion of the Content being reproduced is not altered or made available in a manner that modifies the Content or presents the Content being reproduced in a false light and (iv) notice is made to the disclaimers included on the Content. The permission to re-copy does not allow for incorporation of any substantial portion of the Content in any work or publication, whether in hard copy, electronic or any other form or for commercial purposes.