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TRV-2026-1151Certified recordPeer-reviewed

Artificial Intelligence in Pharmaceutical Regulatory Science: Opportunities, Challenges, and Emerging Frameworks

Digital transformation in pharmaceutical regulatory affairs is accelerating as global submissions grow in complexity and traditional document-based workflows reach their limits. Artificial intelligence (AI), particularly natural language processing (NLP), is increasingly being explored to support regulatory data management, document preparation, and decision support activities. This review examines AI adoption across pharmaceutical regulatory science, including initiatives from major regulatory agencies, AI-supp…

Policy · G Space — documented gain · certified 2026-09-20 · v1 · article view · machine-readable

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Artificial Intelligence in Pharmaceutical Regulatory Science: Opportunities, Challenges, and Emerging Frameworks: However, robust evidence demonstrating sustained improvements in regulatory performance and long-term operational impact remains limited.

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Truvace Impact Record TRV-2026-1151, v1: “Artificial Intelligence in Pharmaceutical Regulatory Science: Opportunities, Challenges, and Emerging Frameworks.” Truvace, 2026-09-20. /record/TRV-2026-1151 (accessed at citation time). sha256 05c479f4178666ab…

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