[FOCUS]Government sophistication to generic regulations
By Chon, Seung-Hyun | translator Choi HeeYoung
19.11.24 13:39:52
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A few years ago, a multinational pharmaceuticals announced “high quality” by launching generics in the domestic market. It is the aspiration to show good quality generics based on strict production management, product monitoring and quality assurance system that have long been recognized in the global market.
At the time, the head of the licensing review department of the Ministry of Food and Drug Safety, who got the news, rejected that "the quality of generic products is meaningless."
Generics must pass strict standards from drug substances to finished product manufacturing facilities. In addition, a conformity test should be made in a bioequivalence study demonstrating that the gener
Chon, Seung-Hyun(1000@dailypharm.com)
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