Regulatory requirements for approval of biological products as per CDSCO in Indian comparison with South Korea
Department of Pharmaceutical Regulatory Science, Sree Siddaganga College of pharmacy B.H Road, Tumkuru-572102. Karnataka, India.
Review Article
World Journal of Advanced Research and Reviews, 2023, 20(01), 758-767
Publication history:
Received on 02 September 2023; revised on 12 October 2023; accepted on 15 October 2023
Abstract:
Biologicals are restorative, therapeutic, analytic, preventive, arrangements created or got from living life forms and their turn for human use. Biological products are expected to continue to play a significant role in the future of medicine and health care. They include vaccines, serum, blood and blood products, gene therapy, antibodies, etc. The Indian administrative expert (CDSCO), is the body which is in charge of the advancement and promoting biologics in India. And in South Korea MFDS is responsible for regulations of biologics.
Objective: Unveiling the differences in regulatory approval aspects and documentation for biological products in India and South Korea as per CDSCO and MFDS respectively. Ensuring the safety, effectiveness, and quality of biological products requires various regulatory processes. These processes typically include rigorous testing, clinical Trails, quality control measure, and regulatory approvals by agencies like CDSCO in India and MFDS in South Korea. These steps are decisive to protect public health and ensure the biological products meet established standards before they made available to patients.
Keywords:
Biological product; CDSCO; RCGM; GEAC; MFDS; KFDA; Comparative study; India; South Korea
Full text article in PDF:
Copyright information:
Copyright © 2023 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0