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@article{204633,
        author = {B Anu},
        title = {Comparative Analysis of Biosimilar Regulatory Frameworks: A Study of USFDA, EMA and CDSCO Approval Pathways},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {1},
        pages = {3309-3314},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=204633},
        abstract = {Background: Clinical trial authorization (CTA) is a critical regulatory mechanism designed to ensure that studies involving human participants are scientifically justified, ethically acceptable, and conducted in compliance with Good Clinical Practice (GCP) standards. Major regulatory authorities, including the U.S. Food and Drug Administration (USFDA), European Medicines Agency (EMA), and Central Drugs Standard Control Organization (CDSCO), have established distinct yet related frameworks for reviewing and approving clinical trials. 
Objectives: To comparatively evaluate clinical trial regulatory frameworks, authorization procedures, ethical oversight mechanisms, and registration requirements in the United States, European Union, and India, and to identify challenges and opportunities for global harmonization. 
Methods: A qualitative, comparative regulatory analysis was conducted using official regulatory guidelines, statutes, and published scientific literature. Data were extracted on legal frameworks, submission pathways, review timelines, ethics committee oversight, safety reporting, trial registration, and post-trial obligations. Comparative tables and process figures were developed to synthesize findings. 
Results: The USFDA operates an IND-based system under 21 CFR Parts 50, 56, and 312 with a defined 30-day review period before trial initiation if no clinical hold is imposed. The EMA uses a centralized Clinical Trial Application (CTA) process through the Clinical Trials Information System (CTIS) under EU CTR 536/2014, combining scientific and ethical assessment across member states. CDSCO regulates trials under the NDCTR, 2019 through the SUGAM portal, with scientific review by Subject Expert Committees (SECs) and mandatory ethics committee approval. All three systems require GCP compliance, informed consent, safety reporting, and trial registration, but differ in operational execution, review structure, transparency mechanisms, and participant compensation requirements. 
Conclusions: The three regulatory systems share common objectives of participant protection, data integrity, and scientific validity, yet maintain region-specific procedural requirements that affect multinational trial planning. Continued harmonization through ICH principles, digital submission platforms, and coordinated regulatory practices may improve efficiency while preserving ethical and scientific standards.},
        keywords = {Clinical Trial Authorization; USFDA; EMA; CDSCO; CTIS; IND; NDCTR; Ethics Committee; GCP; Clinical Trial Registration.},
        month = {June},
        }