ARTIFICIAL INTELLIGENCE IN PHARMACEUTICAL REGULATORY AFFAIRS: REVOLUTIONIZING DRUG DEVELOPMENT, SUBMISSIONS AND REGULATORY COMPLIANCE

Abstract

Objective of this review was to evaluate the evolution, applications, and regulatory implications of artificial intelligence technologies in pharmaceutical regulatory affairs, with emphasis on their influence on drug development, regulatory submissions, and global harmonization. This review examines published literature, regulatory authority documents, and international reports describing the integration of artificial intelligence into regulatory processes. Key technological approaches, including machine learning, natural language processing, and automated workflow systems, were analyzed for their contribution to data assessment, documentation, decision support, and pharmacovigilance activities. Challenges related to data integrity, ethical responsibility, transparency, system validation, and differences in global regulatory expectations were also assessed. Artificial intelligence was found to significantly improve regulatory efficiency by enabling rapid data processing, structured documentation, and predictive regulatory analysis that reduces manual workload and strengthens decision accuracy. Regulatory authorities in multiple regions have begun adopting advanced digital frameworks that support standardized data exchange, collaborative review mechanisms, and more robust monitoring of drug safety. Despite these advancements, concerns remain regarding fairness of algorithms, reliability of automated outputs, protection of confidential information, and the absence of unified international standards. Artificial intelligence technologies provide strong opportunities to streamline regulatory pathways, improve the consistency and reliability of regulatory decisions, and support broader global harmonization. Successful implementation requires proactive attention to ethical, technical, and regulatory challenges to ensure transparent, responsible, and effective integration within pharmaceutical regulatory affairs.