The industry is paying attention to the review of generics

By Lee, Jeong-Hwan | translator Choi HeeYoung

21.04.22 06:00:55

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Next week, the Legislative Subcommittee confirms the evaluation, and the legalization of conditional permits is also made

Including bills for vitalization of generic substitution and mandatory CSO expenditure reports

Following the generic joint bioequivalence test '1+3 Restriction Act', the Drugs for Data-Based Re-evaluation (IMD) clinical data '1+3 Restriction Act' will be submitted to the National Assembly's Health and Welfare committee (Legislative Subcommittee) to be held next week.

The two bills initiated by Democratic Party of Korea Rep. Seo Young-suk and People Power Party Rep. Seo Jeong-sook, respectively, have strengthened their influence on the pharmaceutical industry if passed as a merger review was decided.

A bill to upgrade the CMA (Conditional Marketing Authorization) system for clinical trials operated by the MFDS to the pharmaceutical affairs law has also been newly added as an agenda

Lee, Jeong-Hwan(junghwanss@dailypharm.com)

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