The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly established ten principles for the responsible use of AI throughout the medicines lifecycle. These principles provide broad guidance on AI applications in evidence generation and monitoring, spanning from early research and clinical trials to manufacturing and safety surveillance. Aimed at medicine developers and marketing authorization holders, the principles are intended to underpin future AI guidance within their respective jurisdictions and foster enhanced international collaboration among regulators, technical standard organizations, and other stakeholders. This initiative builds upon the EMA’s AI reflection paper published in 2024 and aligns with the European Commission’s Biotech Act proposal, which highlights AI’s potential to expedite the development of safe and effective medicines.
Click here for the official article/release
Disclaimer
The Legal Wire takes all necessary precautions to ensure that the materials, information, and documents on its website, including but not limited to articles, newsletters, reports, and blogs (“Materials”), are accurate and complete. Nevertheless, these Materials are intended solely for general informational purposes and do not constitute legal advice. They may not necessarily reflect the current laws or regulations. The Materials should not be interpreted as legal advice on any specific matter. Furthermore, the content and interpretation of the Materials and the laws discussed within are subject to change.
