Copyright © 2026 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

@article{204635,
        author = {B Amruthapriyavarshini},
        title = {Accelerated Drug Approval Pathways: Regulatory Strategies for Fast-Track Drug Development},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {1},
        pages = {3325-3328},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=204635},
        abstract = {The increasing prevalence of life-threatening diseases, rare disorders, and global public health emergencies has created a growing demand for expedited regulatory pathways that facilitate rapid access to innovative therapies. Traditional drug approval processes often require extensive clinical development and prolonged review periods, potentially delaying access to critical medicines. To address these challenges, regulatory agencies including the U.S. Food and Drug Administration (USFDA), European Medicines Agency (EMA), and Central Drugs Standard Control Organization (CDSCO) have implemented accelerated drug approval pathways. These mechanisms include Fast Track Designation, Breakthrough Therapy Designation, Priority Review, Accelerated Approval, PRIME Scheme, Conditional Marketing Authorization, Emergency Use Authorization, and expedited review processes. This review evaluates the regulatory frameworks governing accelerated approvals, compares major international approaches, discusses case studies, and examines the benefits, risks, and challenges associated with expedited pathways. The study highlights the importance of balancing rapid patient access with scientific rigor through robust post-marketing surveillance and confirmatory clinical studies. Accelerated approval pathways have significantly improved healthcare outcomes by facilitating earlier access to innovative therapies while supporting pharmaceutical innovation and regulatory efficiency. However, challenges related to limited clinical evidence, surrogate endpoints, pharmacovigilance, and regulatory harmonization remain important considerations for future development.},
        keywords = {Accelerated Approval, Fast Track, Breakthrough Therapy, Priority Review, Conditional Marketing Authorization, PRIME, CDSCO, FDA, EMA, Regulatory Affairs.},
        month = {June},
        }