Artificial intelligence in pharmaceutical regulatory affairs

• Published in: Drug discovery today Vol. 28; no. 9; p. 103700
• Main Authors: Patil, Ruchika S., Kulkarni, Samruddhi B., Gaikwad, Vinod L.
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.09.2023
• Subjects: dossier; regulatory affairs; audit; artificial intelligence; regulations
• ISSN: 1359-6446; 1878-5832
• DOI: 10.1016/j.drudis.2023.103700

•AI can be used to simplify and automate pharmaceutical regulatory processes.•AI reduces complexity, resulting in a more efficient management system.•AI reduces the time spent on quality management and identify vulnerabilities.•Human-AI interaction opens up new opportunities in regulatory compliance.•The potential role of AI in pharmaceutical regulatory affairs is explored. Artificial intelligence (AI) refers to the ability of a computer to carry out tasks associated with human intelligence, including thinking, discovering, and learning from prior experience. AI can be integrated to simplify the complexity of pharmaceutical regulatory affairs. AI tools can be applied to automate regulatory processes such as administrative work, dossier filling, data extraction, auditing, the implementation of regulations, and quality management. AI creates process links and reduces complexity, resulting in a more efficient management system. Human–AI interaction opens up new opportunities in regulatory affairs. This article explores the potential role of AI in pharmaceutical regulatory affairs.