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@article{202124,
        author = {NALLAMEKALA RAGHAVI},
        title = {Regulatory Requirements For Clinical Trials: A Comparative Study Of USFDA, EMA and Indian Regulations},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {12},
        pages = {6064-6067},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=202124},
        abstract = {Clinical trials are an essential component of pharmaceutical drug development, serving as the primary mechanism for evaluating the safety, efficacy, and quality of investigational medicinal products before they are approved for public use. Regulatory authorities across the globe have established structured frameworks to ensure that clinical trials are conducted ethically and scientifically while safeguarding human participants. The present study focuses on a comparative analysis of clinical trial regulations followed by the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), and India’s Central Drugs Standard Control Organization (CDSCO). The study evaluates major regulatory requirements including clinical trial authorization procedures, ethical approvals, informed consent requirements, safety reporting mechanisms, trial registration systems, and post-trial obligations. The USFDA follows a highly structured Investigational New Drug (IND) pathway supported by Institutional Review Board (IRB) oversight. The EMA regulates clinical trials through the Clinical Trial Regulation (EU CTR 536/2014) and utilizes the Clinical Trials Information System (CTIS) for centralized submissions. India regulates trials through the New Drugs and Clinical Trials Rules (NDCTR), 2019 under CDSCO, emphasizing participant compensation and ethical accountability. The study identifies similarities and differences among these regulatory frameworks and highlights major challenges such as regulatory variability, approval delays, ethical concerns, and data integrity issues. Findings indicate that although harmonization efforts through ICH-GCP guidelines have improved global consistency, complete regulatory alignment remains challenging. Strengthening international collaboration and adopting digital regulatory systems can improve efficiency in global clinical trial approvals.},
        keywords = {Clinical Trials, USFDA, EMA, CDSCO, IND, CTIS, NDCTR 2019, Regulatory Affairs, Ethics Committee, Clinical Trial Registration},
        month = {May},
        }