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@article{202134,
        author = {PATIL NARMADA and M S Riyazullah and B K Babu},
        title = {Accelerated Drug Approval Pathways: Regulatory Strategies for Fast-Track Drug Development},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {12},
        pages = {6447-6450},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=202134},
        abstract = {The conventional drug approval process is highly rigorous and time-consuming, often requiring several years of clinical evaluation before a pharmaceutical product reaches the market. While this traditional pathway ensures safety, efficacy, and quality, it may delay access to life-saving therapies for patients suffering from serious, rare, or life-threatening diseases. To address these challenges, global regulatory authorities have introduced accelerated drug approval pathways that facilitate faster access to innovative medicines while maintaining regulatory oversight.
The present study focuses on evaluating accelerated drug approval mechanisms adopted by major regulatory agencies including the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), and Central Drugs Standard Control Organization (CDSCO). The study examines regulatory frameworks such as Fast Track designation, Breakthrough Therapy designation, Priority Review, Accelerated Approval, Conditional Marketing Authorization, PRIME scheme, and expedited approvals under India’s NDCTR 2019.
The study also evaluates the role of surrogate endpoints, adaptive clinical trial designs, real-world evidence, and post-marketing surveillance in supporting accelerated approvals. Comparative analysis reveals that although these pathways significantly reduce approval timelines and improve patient access, they also present regulatory challenges related to limited clinical evidence, safety concerns, and post-marketing obligations. The findings emphasize the importance of balancing innovation with scientific rigor and strengthening global regulatory harmonization for future drug development.},
        keywords = {Accelerated Approval, Fast Track, Breakthrough Therapy, Priority Review, EMA, CDSCO, Regulatory Affairs, Drug Development, Pharmacovigilance, Conditional Approval},
        month = {May},
        }