Dr Ashok Kumar P

ABSTRACT: Artificial Intelligence (AI) is emerging as a transformative technology in pharmaceutical regulatory affairs, enhancing efficiency, accuracy, and regulatory decision-making throughout the product lifecycle. Recent studies have demonstrated the application of AI and Machine Learning (ML) in regulatory intelligence, dossier preparation, document management, pharmacovigilance, signal detection, and compliance monitoring. Regulatory agencies worldwide are increasingly exploring AI-driven approaches to streamline regulatory submissions and improve review processes while maintaining safety, efficacy, and quality standards. This review aims to evaluate the role of AI in transforming regulatory affairs and to compare the adoption and implementation of AI-enabled regulatory practices by the Central Drugs Standard Control Organization (CDSCO), India, and Health Canada. The study examines current applications of AI in regulatory operations, including automated document review, adverse event monitoring, data analytics, and decision-support systems. Furthermore, it assesses the opportunities, challenges, and regulatory considerations associated with AI integration, such as data governance, transparency, validation, ethical concerns, and workforce readiness. The study concludes that AI has the potential to reshape the future of regulatory science by improving operational efficiency and regulatory effectiveness. Strategic adoption of AI technologies by regulatory authorities can contribute to faster access to safe and effective medicines while maintaining high regulatory standards4.