This report presents a cross-industry perspective on how AI governance can be integrated effectively into medicinal product research and development (R&D) and post-authorization settings, with a focus on ensuring trust, transparency, and regulatory alignment through ongoing dialogue between industry and regulators.

Artificial Intelligence (AI) is transforming the pharmaceutical landscape, offering unprecedented opportunities across the medicine’s lifecycle, from drug discovery and clinical development to manufacturing and post-approval safety monitoring. As AI becomes more deeply embedded in regulatory decision-making and processes that impact patients, the need for robust governance becomes critical.