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[FOCUS] Uncomfortable co-development regulation of medicines

By Chon, Seung-Hyun | translator Choi HeeYoung

21.05.11 06:13:09

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There is a growing possibility that a bill will be implemented to regulate joint drug development by pharmaceutical companies. Recently, the National Assembly's Health and Welfare Committee held a bill subcommittee to pass a partial revision to the pharmaceutical practices law that limits the number of drugs that can be licensed through a single clinical trial. It allows up to four drugs that can be licensed with one biological equivalence test or clinical trial data. It does not apply to biopharmaceuticals or generic drugs. Biological equivalence testing is a kind of clinical trial for generic development, which effectively limits drug co-development by pharmaceutical companies.

In fact, regulating the

Chon, Seung-Hyun(1000@dailypharm.com)
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