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  • All prescription drugs to hand in bioequivalence test result
  • by Lee, Tak-Sun | translator Byun Kyung A | Nov 20, 2019 06:33am
3-step expansion on subjects, in order of oral, aseptic techniques, and others
Response to too many generics in market, bioequivalence regulation to cost 164.4 billion won
Specification submission leaves no exception, CMOs to also hand in GMP evaluation results
Subject for bioequivalence test is to expand out to all prescription drugs. Also, drug specification with test criteria and procedure would be required, as well as Good Manufacturing Practice (GMP) evaluation result from external contract manufacturing companies.

Korean Ministry of Food and Drug Safety (MFDS) announced on Nov. 18 its plan to enact partially revised ¡®Regulation on Pharmaceutical Safety¡¯, as a follow-up to the excessive commercialization of generics and last year¡¯s valsartan incident with carcinogen contamination. The ministry is to accept public opinion on the matter until Jan. 20, 2020.

For Korean pharmaceutical industry that bases most of business off of generic products, the revised regu
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