Eight Hallmarks for Governing Artificial Intelligence in Medical Affairs: A Structured Pathway for Responsible AI Adoption

Medical Affairs (MA) is the pharmaceutical medicine discipline responsible for medically governed scientific exchange, post-approval evidence generation, and stakeholder engagement. As MA adopts artificial intelligence (AI), governance must keep pace. We propose that AI use be directed by MA accountability and named human medical judgement. The European Union (EU) AI Act's transparency provisions generally apply from August 2026. Its high-risk requirements apply from 2 December 2027 for Annex III systems and 2 August 2028 for systems classified through Annex I. In this narrative review, we critically examine the emerging evidence base and current regulatory guidance to propose eight hallmarks characterising AI-enabled MA. Four are foundational governance capabilities: scientific and ethical integrity, evidence generation at scale, advanced scientific communications, and global alignment and regulatory adaptation. Four are emerging applications requiring validation: AI-empowered strategic leadership, AI-enhanced stakeholder engagement, field medical excellence, and digital innovation and agentic AI systems. Named human accountability underpins all eight hallmarks. We provide pharmaceutical leaders with author-proposed implementation tools including a maturity assessment model, a mapping of common MA AI use cases to EU AI Act obligations, a medical-legal-regulatory workflow for AI-generated content, and equity-by-design metrics. The framework proposes a governance-first, structured pathway for responsible AI adoption in MA that is designed to preserve scientific integrity.