Artificial intelligence has rapidly moved from a promising experimental tool to a foundational element across the medicines lifecycle. Today, AI underpins early discovery, optimizes clinical trial design, enhances manufacturing controls and strengthens post-marketing safety surveillance. For regulators and industry alike, its value lies in the promise of greater speed, increased efficiency and improved patient outcomes.
Yet the pace of adoption has also surfaced familiar concerns: scientific robustness, transparency, data provenance, explainability, and the risks of overreliance on opaque systems. Recognising both the potential and the pitfalls, the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have jointly issued ten guiding principles for good AI practice across the medicines lifecycle, establishing a shared reference point for global regulatory alignment. [ema.europa.eu], [fda.gov]
A Pragmatic Framework for a Transforming Sector
The regulators’ message is deliberately balanced: innovation should not come at the expense of patient safety, scientific integrity or regulatory accountability. Their principles – ranging from human‑centric design and risk‑based oversight to data governance, lifecycle management and adherence to standards – reflect a clear shift toward a structured, globally coordinated approach to AI governance.
Importantly, both agencies emphasize that the framework is principles‑based rather than prescriptive. This flexibility is intentional. AI technologies evolve faster than regulations can be drafted, and a rigid rulebook would quickly become obsolete. Instead, EMA and FDA aim to set durable expectations that can guide developers even as models, datasets and applications change. The principles will also serve as the foundation for more detailed guidance already under development within the EU.
Transatlantic Alignment as a Strategic Imperative
This initiative builds on longstanding EMA–FDA cooperation and follows the renewed commitment made during the FDA‑EU bilateral meeting in 2024. Their alignment is not merely procedural, it is strategic.
Regulators on both sides of the Atlantic recognize that AI governance must be globally coherent to preserve innovation leadership, reduce regulatory fragmentation and reinforce patient trust. As European Commissioner for Health and Animal Welfare Olivér Várhelyi put it, the principles demonstrate how international cooperation can advance innovation while upholding the highest standards of safety.
For pharmaceutical companies, medical device manufacturers and digital health innovators, this convergence reduces uncertainty and provides a clearer path for bringing AI‑enabled technologies to market in multiple jurisdictions.
The Road Ahead: Governing What Will Inevitably Shape the Future of Medicine
The question for the sector is no longer whether AI will reshape drug development and regulatory science. It already has. Instead, the defining challenge will be how wisely, transparently and responsibly we choose to govern it.
The EMA–FDA principles mark a significant step: they codify shared expectations, reinforce scientific discipline and elevate accountability without impeding innovation. Companies that integrate these principles into their design, validation and oversight processes today will be better positioned to navigate the evolving regulatory landscape and to demonstrate trustworthy, safe and high‑quality AI systems tomorrow.
The full list of the ten guiding principles is available here:
👉 https://www.ema.europa.eu/en/news/ema-fda-set-common-principles-ai-medicine-development-0
About the DORDA Health & Life Science Group
DORDA’s Health & Life Science Group advises clients across the full regulatory and commercial spectrum of pharmaceutical products, medical devices, MedTech, biotech and digital health solutions. The Group combines deep sector knowledge with interdisciplinary legal expertise, enabling clients to navigate complex regulatory requirements, manage risk and accelerate innovation in highly regulated markets. Our team is integrated into leading European networks, ensuring forward‑looking and internationally aligned counsel.
This article was authored by Francine Brogyányi, Managing Partner at DORDA and head of the firm’s Health & Life Science Group. She is recognized as one of the leading experts for Life Sciences law in Austria and the EU and advises companies across Pharma, MedTech, Biotech and Digital Health on regulatory, compliance and strategic matters throughout the entire product lifecycle.