2025-05-12
A new EU workplan outlines how data and AI will shape the future of medicines regulation, aiming to deliver safer treatments faster across Europe.
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have jointly published a forward-looking workplan, Data and AI in Medicines Regulation to 2028. This initiative aims to strengthen how regulatory and health data are used to improve research, drive innovation, and accelerate access to safe and effective medicines.
As the volume of digital health data grows, regulators across Europe are uniting to adopt smarter tools, including artificial intelligence (AI). The workplan outlines how data will be managed, analysed, and shared under high security and ethical standards, ultimately supporting faster and more informed regulatory decisions.
Moreover, it aligns with major EU initiatives like the European Health Data Space (EHDS), the AI Act, and pharmaceutical legislation reforms. These frameworks emphasize collaboration and consistency in data use across the EU.
A newly formed advisory group, the Network Data Steering Group (NDSG), will oversee the implementation of this strategy. This group merges the expertise of the previous Big Data Steering Group and the Network Data Board.
“We need to be strategically aligned across the EU to turn data into tangible public and animal health benefits,” said Peter Arlett, EMA’s Head of Data Analytics and Methods Task Force.
“Through stakeholder collaboration and guidance, we aim to deliver real outcomes across the EU,” added Karl Broich, president of the German Federal Institute for Drugs and Medical Devices (BfArM).
Key objectives of the workplan include:
Boosting the network’s analytics capabilities to support evidence-based decisions.
Continuing pilot projects that explore patient-level clinical trial data.
Expanding the role of DARWIN EU®, which delivers real-world evidence to fill gaps in medicine safety and effectiveness.
Additionally, the plan emphasizes evaluating both traditional and novel data types, such as genomic data, digital twins, synthetic data, and patient-reported outcomes.
One core priority is improving the discovery, access, and reuse of data across EU systems. The workplan outlines steps to:
Enhance real-world data quality.
Catalogue adverse drug reaction data.
Advance the Product Management Service (PMS), which manages medicinal product master data critical for EU-wide use cases.
This focus on interoperability ensures that key data assets can support healthcare systems across borders, including those working in cell therapy, gene therapy, and ATMPs (Advanced Therapy Medicinal Products).
AI offers vast potential across the medicine lifecycle—from drug development to pharmacovigilance. The workplan commits to:
Supporting scientific evaluations of AI in regulatory decisions.
Providing guidance on AI use in clinical trials and safety monitoring.
Encouraging international cooperation.
Delivering training and tools to help regulators safely use AI.
The aim is to ensure AI is integrated in a way that prioritizes public health, transparency, and ethical use.
Why This Matters for Sweden and ATMP Development
For organizations in the ATMP space—including those advancing cell & gene therapies—this EU alignment creates a more predictable and supportive regulatory environment. Coordinated data practices and the responsible use of AI will help speed up access to innovative medicines for Swedish patients.
As Sweden works toward becoming a global leader in Advanced Therapy Medicinal Products by 2030, these developments provide valuable foundations for harmonized, data-driven progress.