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  • The industry is paying attention to the review of generics
  • by Lee, Jeong-Hwan | translator Choi HeeYoung | Apr 27, 2021 06:04am
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 for review of the legis
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