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@article{202010,
        author = {S KIRANKUMAR and AUDINARAYANA NELAVALA},
        title = {ROLE OF ARTIFICIAL INTELLIGENCE IN REGULATORY AFFAIRS: OPPORTUNITIES AND CHALLENGES IN DRUG APPROVAL},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {12},
        pages = {5812-5816},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=202010},
        abstract = {Artificial Intelligence (AI) has emerged as a transformative force in pharmaceutical regulatory affairs, offering innovative solutions to address the growing complexity of drug development and approval processes. Traditional regulatory systems rely heavily on manual data evaluation, which is often time-consuming, resource-intensive, and prone to human error. With the exponential increase in clinical, non-clinical, and real-world data, there is a critical need for advanced technologies capable of managing and interpreting such large datasets efficiently. AI technologies, including machine learning, natural language processing, and predictive analytics, provide powerful tools to enhance regulatory workflows such as dossier preparation, regulatory submissions, clinical data analysis, and pharmacovigilance.
Regulatory authorities such as the U.S. Food and Drug Administration, European Medicines Agency, Central Drugs Standard Control Organization, World Health Organization, and International Council for Harmonisation are actively exploring AI-based regulatory frameworks to improve efficiency, transparency, and decision-making in drug approval processes. AI has demonstrated significant potential in accelerating regulatory timelines by enabling rapid analysis of large datasets and improving the accuracy of regulatory decisions. However, challenges such as data integrity issues, lack of algorithm transparency, ethical concerns, and absence of standardized global regulatory frameworks pose significant barriers to its widespread adoption.
This study provides a comprehensive evaluation of the role of AI in regulatory affairs, focusing on its applications, benefits, regulatory challenges, and future prospects. The findings emphasize that while AI offers substantial opportunities to revolutionize regulatory science, its successful implementation requires robust regulatory oversight, ethical governance, and global harmonization.},
        keywords = {Artificial Intelligence, Harmonisation, Framework.},
        month = {May},
        }