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@article{188545,
        author = {Pratham Rajesh Jaiswal and Mr.Avinash.D.Hatkar and Dr.Sunil.Jaybhaye and Mr.Vinayak.S.Wadhekar},
        title = {Comparative Studies for Drug Approval Process in India, USA, Europe and also an Overview on the Emerging Pharmaceutical Markets in Global Drug Regulatory Affairs.},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {7},
        pages = {1898-1907},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=188545},
        abstract = {Drug Regulatory Affairs (DRA) plays a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products on a global scale. As the pharmaceutical industry continues to expand and innovate, regulatory systems have become increasingly important for protecting public health and maintaining ethical in drug development. This project provides a comprehensive overview of Drug Regulatory Affairs across major international markets, highlighting the regulatory frameworks, processes, and challenges that shape global drug approval pathways. The study begins with an introduction to the origins and evolution of drug regulation, emphasizing the key events that led to the establishment of modern regulatory bodies. It then explores the drug development process, from preclinical research to post marketing surveillance, outlining the essential documentation such as Common Technical Document (CTD), Investigational New Drug (IND) applications, and New Drug Applications (NDA). Special focus is placed on Good Regulatory Practices including GMP, GCP, GLP, and GVP that guide the quality and ethical standards throughout a drug lifecycle.},
        keywords = {},
        month = {December},
        }