In May 2025, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA – the body that coordinates the European Union’s national medicines agencies) announced the 2025–2028 strategic plan, “Data and AI in Medicines Regulation to 2028“, establishing guidelines for the use of data, advanced analytics, and artificial intelligence (AI) in the regulation of medicines.
This plan was aligned with the European Union’s legislative and digital initiatives, including the revision of pharmaceutical legislation, the European Health Data Space (EHDS), and the AI Act (regulation on the use of artificial intelligence in the European Union). 

At the time, Peter Arlett (EMA) and Karl Broich (BfArM) emphasized that coordination between countries, technical training, and international collaboration would be essential to transform technological advances into real benefits for human and animal health. It was also established that the EMA would support industry and scientific committees with guidelines for the use of AI in all stages of the medicine’s lifecycle. 

 Recent Progress: Publication of the 2024 AI Observatory Report 

In July 2025, the EMA published the first annual Artificial Intelligence Observatory Report (2024 AI Observatory report) of the European medicines regulatory network. This report compiles the network’s experience with artificial intelligence during 2024 in enhancing productivity, automating tasks, and supporting data-driven decisions across a medicine lifecycle. In addition to the report, two other related documents were also made available: 

• A compilation of examples of AI use in medicine regulation (2024 AI Observatory report: Compilation of 2024 experience) 

• A horizon scanning short report (Review of artificial intelligence and machine learning applications in medicines lifecycle 2024: Horizon Scanning Short Report) 

This report includes a Horizon Scanning study — which is a systematic monitoring methodology for trends, innovations, and potential risks, based on peer-reviewed scientific literature, preprints, and projects funded by the European Union. The goal is to identify new technologies, innovations, practices, and emerging changes before they become widely adopted and could impact the development, evaluation, and surveillance of medicines. This enables regulators to prepare for new types of studies, data, or methodologies, ensuring that legislation, guidelines, and technical expertise are ready to evaluate disruptive technologies (such as new AI applications) in areas such as drug discovery, clinical trial design, or pharmacovigilance.
For this analysis, the TRIP tool (Topics, Relationships, Impact assessment, Proposal generation) was used to map peer-reviewed scientific literature, preprints, clinical trial registries, EU-funded projects, and documents from international agencies, between January and November 2024. 

This work is part of the strategic plan “Data and AI in Medicines Regulation to 2028“. 

 Key Data and Findings 

• From the “2024 AI Observatory report” (EMA Summary Report) 

This report provides strategic and analytical insights into AI use in the European regulatory network: 

• It compiles experience gained with AI tools in use in 2024, including those from national agencies, with the aim of automating processes, improving productivity, and supporting decision-making. 

• It also documents the EMA’s participation in AI tool qualification processes and scientific advice procedures related to the topic. 

• In addition, it highlights emerging AI applications throughout the medicine’s lifecycle. These include areas such as drug target identification, manufacturing process monitoring and control, patient selection in clinical trials, use of digital twins, and pharmacovigilance (adverse event detection and reporting). 

• From the document “2024 AI Observatory report: Compilation of 2024 experience”
  This document compiles practical examples and trends observed throughout the year. The applications identified include AI use for increasing insights into data and supporting decision-making in medicine lifecycle identified as part of Qualification of novel methodologies for medicine development, Scientific Advice, Innovation Task Force meetings and Portfolio and Technology meetings. It also covers AI tools designed to optimize personal productivity and internal workflows, as well as to automate the processes and systems used by both the EMA and EU national agencies. 

• From the “Horizon Scanning Short Report – Review of AI/ML applications in medicines lifecycle (2024)” 

This document details practical examples and the methodology behind the Horizon Scanning study: 

• It describes how the EMA used the TRIP tool to analyze sources such as scientific articles, preprints, clinical trial registries, EU-funded projects, and reports from agencies such as the FDA and WHO, among other sources, between January and November 2024. 

• It provides examples of AI applications in each phase of the medicine development and lifecycle and describes some opportunities and challenges identified by developers: 
• 1. Drug discovery – Examples: drug target identification, compound design, drug repurposing, interaction prediction. 
  1. Non-clinical development – Examples: pharmacokinetic (PK) and toxicity prediction, blood-brain barrier penetration prediction, reduce the use of animals in medicine development. 
  1. Clinical trials – Examples: participant recruitment, patient stratification, use of digital twins. 
  1. Precision medicine – Examples: personalized posology/dosing adjustments and identification of novel biomarkers for individualized therapy. 
  1. Product information – Examples: automation of package inserts writing and updates and other regulatory documents. 
  1. Manufacturing – Examples: process optimization, quality control, batch release. 
  1. Post-authorization – Examples: early detection of adverse drug reactions, automatic signal detection from Electronic Health Records. 

These examples are well documented throughout the sections of this document, including the opportunities and challenges they present. 

The document also highlights that data protection and privacy are among the main challenges identified in several studies. Another limitation is the quality and quantity of data required to feed the presented models and improve predictions. 

The report concludes that AI represents an excellent opportunity to improve processes in regulatory agencies, but there is the need to adapt frameworks and processes to accommodate the use of AI in internal processes. This includes implementing AI tools, updating guidelines and ensuring that regulatory staff are trained to evaluate AI-driven assessments. 

 Coordination and Regulation of AI Use in the Medicines Lifecycle 

The European Medicines Regulatory Network (EMRN), comprising the EMA, the competent national authorities of EU/EEA Member States and the European Commission, ensures harmonized regulations of medicines throughout the EU. 

In the context of artificial intelligence, the EMRN acts as the collaborative structure that enables the development, testing, and application of AI tools across the entire medicine’s lifecycle in a coordinated manner. It is within this network that experiences, data, and best practices are shared to ensure consistency and technical quality in evaluations. 

The Network Data Steering Group (NDSG), which is jointly managed by the EMA and the HMA, is the EMRN body responsible for coordinating policies, strategies, and analytical capabilities related to the use of data and AI. Created in January 2025 to succeed the Big Data Steering Group (BDSG), the NDSG oversees the annual publication of the AI Observatory Report and ensures that the conclusions of Horizon Scanning and other studies are incorporated into the network’s regulatory practices. 

The AI Act — the European Artificial Intelligence Regulation — provides the legal framework that defines mandatory requirements for safety, transparency, risk management, and protection of fundamental rights for the development, use, and supervision of AI systems used in the pharmaceutical sector, including those applied in medicines development, evaluation, and monitoring. Its application means that AI solutions used in the medicine’s lifecycle must meet specific quality, documentation, and risk assessment requirements. 

 Implications for the Pharmaceutical Industry 

The publication of EMA’s AI reports signals important changes to the development and regulation of medicines within the EU. Companies adopting AI for drug discovery, clinical trials, manufacturing, and pharmacovigilance will gain competitive advantages, provided they ensure human validation, governance, and oversight in accordance with the AI Act. In addition to speeding up processes, enabling document automation and the use of real-world data, the use of AI can reduce costs and timelines. However, quality controls and transparency are required to obtain regulatory acceptance. 

 Why is this important for the non-EU pharmaceutical industry? 

To access or maintain medicines on the European market, non-EU pharmaceutical companies will need to adapt their AI processes to the requirements of the AI Act and the guidelines of the European Medicines Regulatory Network. This means preparing compliant documentation, adopting good data governance practices, and exploring partnership and innovation opportunities with European centers. Anticipating these requirements can avoid the need for additional revisions, speed up the submission process, and boost competitiveness in the global market. 

 Find out more at: 

• 2024 AI Observatory Report – EMA 

• “Data and AI in Medicines Regulation to 2028” plan 

 Access complete information on Artificial Intelligence on the EMA website at: Artificial intelligence | European Medicines Agency (EMA) 

 At Vita Pharma Consulting, we closely monitor international regulatory trends and support companies in adapting processes and documentation to meet European AI requirements, ensuring more agile and secure submissions aligned with EMA expectations. 

Count on Vita Pharma Consulting to turn innovation into compliance and accelerate your medicine’s access to the European market.