aceArtificial 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…
Robust evidence of sustained improvements in regulatory performance and long-term impact from AI in pharmaceutical regulation remains limited.
Evidence
- Peer-reviewedThe AAPS Journal2026-09-18
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Truvace Impact Record TRV-2026-1151, v2: “Artificial Intelligence in Pharmaceutical Regulatory Science: Opportunities, Challenges, and Emerging Frameworks.” Truvace, 2026-10-26. /record/TRV-2026-1151 (accessed at citation time). sha256 05defd2d45e4e473…
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