Artificial Intelligence in Pharmaceutical Regulatory Affairs: An Introduction
1, 2, 2
- 1Department of Pharmaceutical, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka, INDIA.
- 2Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka, INDIA.
CORRESPONDENCE
Mr. Kumar Chandrasekaran
Department of Pharmaceutical Sciences, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka, INDIA.
Received: 28-12-2024; Revised: 07-02-2025; Accepted: 16-06-2025.
Volume 14, Issue 2 · pp. 235-239 · 2025 · DOI: 10.5530/ajbls.20251167
ABSTRACT
Navigating the pharmaceutical regulatory landscape is notoriously time-intensive, primarily due to its intricate nature and constant evolution. Traditional approaches to regulation are often cumbersome and slow, whereas Artificial Intelligence (AI) has already made significant inroads into various facets of the pharmaceutical industry. AI is now poised to transform pharmaceutical regulatory affairs, a critical domain responsible for overseeing drug approval processes, ensuring compliance with regulatory standards, and facilitating communication with regulatory bodies. This field is marked by its complexity, vast data requirements, and the necessity for precise accuracy, all of which pose substantial challenges. AI brings innovative solutions to the table, significantly improving efficiency, accuracy, and strategic decision-making. This article aims to introduce the foundational aspects of AI in pharmaceutical regulatory affairs by highlighting the key areas where AI is making an impact, the challenges and considerations involved, and the benefits it brings to the table. Ultimately, AI offers transformative potential for pharmaceutical regulatory affairs, addressing its inherent challenges and fostering advancements in efficiency, precision, and strategic planning.
KEYWORDS
REFERENCES
As publishedShowing references and in-text citations exactly as published.
Cite this article
SELECT FORMAT
Chandrasekaran, K., Kumar, T. M. P., & V, B. (2025). Artificial Intelligence in Pharmaceutical Regulatory Affairs: An Introduction. Asian Journal of Biological and Life Sciences, 14(2), 235-239. https://doi.org/10.5530/ajbls.20251167
Copyright and licence
© 2025 Author(s)
This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. CC BY 4.0