Department of Pharmaceutical Regulatory Science, Shree Siddaganga college of Pharmacy, Mahalaksmi Naga, Batawadi Tumkur-572103. Karnataka, India.
World Journal of Advanced Research and Reviews, 2024, 23(03), 2960–2968
Article DOI: 10.30574/wjarr.2024.23.3.2940
DOI url: https://doi.org/10.30574/wjarr.2024.23.3.2940
Received on 22 August 2024; revised on 25 September 2024; accepted on 28 September 2024
The Drug master file (DMF) is a type of Confidential file that submitted to regulatory authorities about the ingredients, process, packing and storage of any drugs intended to human use. Drug master file plays an important role in production of drug. The Indian regulatory agency is a CDSCO that manages and encourage DMFs in India and in South Korea MFDS manages the DMFs. Unveiling the difference in regulatory requirements and filling procedure of DMF in India and South Korea as per CDSCO and MFDS respectively. Make certain the Protection, Grade, and Effectiveness of Drug Products.
Drug master file; CDSCO; CTD; QOS; MFDS; Comparative Study
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Ashok kumar P, Nikhil HV, Rohith B, Venu T, Vinutha HG and Sandeep KV. Regulatory requirement and filling procedure of drug master file in India under central drug standard control organization (CDSCO) in comparison with South Korea. World Journal of Advanced Research and Reviews, 2024, 23(03), 2960–2968. Article DOI: https://doi.org/10.30574/wjarr.2024.23.3.2940
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