Comparative study of updated Clinical Trial Regulations in India with respect to Australia, Europe, Japan and US
Abstract
The national regulatory authorities, such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Central Drugs Standard Control Organization and the Australian Therapeutic Goods Administration (TGA), approve every drug that is prescribed for patients around the world. The process of approval undertaken by pharmaceutical companies for drug candidates consists of a series of phases to ensure the product is safe and effective at treating the disease.
In this paper, we will compare the clinical trial regulations of India with respect to Australia, Europe, Japan & USA in order to determine the safety and efficacy of pharmaceutical products like drugs, biologics and medical devices in different geographical regions and to confirm the clinical trials studies follow strict scientific standards.
Keywords:
Clinical Trials, Post Marketing Surveillance, FDA, CDSCO, EMA, TGA, MHWF, Regulatory Framework, Institutional Review Board, CTX Application, Investigational New Drug Application
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References
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Kumar, D., shivali rahi, and A. Rana. “Comparative Study of Updated Clinical Trial Regulations in India With Respect to Australia, Europe, Japan and US”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 1, Mar. 2021, pp. 48-61, doi:10.22270/ijdra.v9i1.455.
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