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.
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