艾昆纬-对药品安全领域的人工智能治理提出更高要求（英）

White PaperDemanding More from AI Governance in Drug Safety By MARIE FLANAGAN, Regulatory and AI Governance Lead, Safety Technologies, IQVIASource: IQVIATable of contentsThe regulatory climate: where do we stand? 1The challenges: what are we up against? 2The solutions: how do we safely move the dial from traditional to generative AI? 3The partnerships: what questions should we be asking? 5The horizon: what’s stopping you? 5References 6About the authors 6About IQVIA 6 iqvia.com | 1Artificial Intelligence (AI) usage continues to expand in the pharmaceutical space with many drug companies considering how to implement this technology to increase efficiency and enhance decision making across the lifecycle of a drug, the Marketing Authorization Holders (MAHs) must also ensure compliance amid an evolving regulatory landscape. Regulators have encouraged the use of AI in drug development and manufacturing, but their guidance remains largely in draft form and is subject to change as new insights come to light. The regulatory climate: where do we stand?As of January 2025, 69 countries had proposed or implemented >1,000 AI-related policy initiatives and legal frameworks.1 Published in 2024, the EU AI Act addresses healthcare and therein, high-risk AI systems; it is the world’s first and arguably most influential comprehensive legal framework for AI. It sets a global benchmark by adopting a risk-based approach and imposing obligations proportionate to the potential impact of AI systems.Despite calls from major European tech leaders to delay its rollout, the European Commission has made it unequivocally clear: there will be no pause, no grace period, and no delay in the implementation of the EU AI Act. The first set of rules came into force in February 2025, and key obligations for high-risk AI systems, i.e., those deemed to pose significant risks to fundamental rights, health, or safety, will become binding from August 2, 2026. At the same time, the commission has emphasized that organizations do not need to wait for detailed prescriptions to act. Companies are expected to proactively align with the intent of the Act, and failure to do so could result in significant penalties: up to €35 million or 7% of global annual turnover.In 2025, the U.S. government issued two memoranda — M-25-21 and M-25-22 — directed toward federal agencies, which firmly established the country’s pro-innovation stance on AI. These documents made it clear that AI adoption is encouraged, provided it is supported by robust, risk-based assessments. Japan has echoed a similar position, emphasizing innovation while maintaining a strong focus on risk management. The message is clear: regulatory clarity is not a prerequisite for responsibility. Organizations are encouraged to move forward confidently, provided they adhere to the guiding principles and frameworks already established.Furthering the cause, the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and U.K.