Review ArticleInternational Journal of Pharmaceutical InvestigationVol. 16 | Issue 1 | 2026 | pp. 23–29Open access
A Global Perspective on Navigating the Regulatory Landscape of Adaptive AI in Healthcare: Balancing Innovation and Patient Safety
- 1,
- 2,
- 3,
- 4,
- 1*
- 1 Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Nilgiris, Tamil Nadu, INDIA.
- 2 Department of Pharmaceutical Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Nilgiris, Tamil Nadu, INDIA.
- 3 Pharmaceutical Development, Aurigene Oncology Limited, Bengaluru, Karnataka, INDIA.
- 4 Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Nilgiris, Tamil Nadu, INDIA.
Published in International Journal of Pharmaceutical Investigation
Correspondence: Srikanth Jupudi
Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Nilgiris, Tamil Nadu, INDIA.
Email: sjphd@jssuni.edu.in
Copyright: © 2026 Manuscript Technomedia. This is an open access article.
- Published:
- Jan 1, 2026
- Received:
- Jun 2, 2025
- Accepted:
- Sep 15, 2025
- DOI:
- 10.5530/ijpi.20260314
How to cite
Talari, S., Murthannagari, V. R., Kumar, G. K. P., Kuppusamy, G., & Jupudi, S. (2026). A Global Perspective on Navigating the Regulatory Landscape of Adaptive AI in Healthcare: Balancing Innovation and Patient Safety. International Journal of Pharmaceutical Investigation, 16(1), 23–29. https://doi.org/10.5530/ijpi.20260314
Abstract
In healthcare, adaptive AI and machine learning offer continuous performance improvement through patient data updates, but traditional regulation methods are slow and cumbersome. The USFDA and EMEA propose a paradigm shift, focusing on oversight of quality management systems and algorithm change protocols to ensure patient safety while enabling advancements. Regulatory challenges arise from the need for frequent updates, which require a robust and efficient method. This article explores the regulatory landscape for AI-based medical devices highlighting efforts by Japan, the EU, and the US, and the perspectives of organizations like IMDRF and WHO.
Keywords
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Article metadata
| Title | A Global Perspective on Navigating the Regulatory Landscape of Adaptive AI in Healthcare: Balancing Innovation and Patient Safety |
|---|---|
| Authors | Sandeep Talari; Vivek Reddy Murthannagari; Gundavarapu Kanaka Phani Kumar; Gowthamarajan Kuppusamy; Srikanth Jupudi |
| Affiliations | Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Nilgiris, Tamil Nadu, INDIA.; Department of Pharmaceutical Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Nilgiris, Tamil Nadu, INDIA.; Pharmaceutical Development, Aurigene Oncology Limited, Bengaluru, Karnataka, INDIA.; Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Nilgiris, Tamil Nadu, INDIA. |
| Corresponding author | sjphd@jssuni.edu.in |
| Journal | International Journal of Pharmaceutical Investigation |
| Volume / Issue | Vol. 16, Issue 1 (2026) |
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