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Cases of Vivozon & Binex need ¡®1+3 Regulation Act¡¯

By Lee, Jeong-Hwan | translator Choi HeeYoung

21.03.14 15:45:28

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Proposed by Rep. Young-Seok Seo, the passing of the generic regulation bill is a pre-determined fact

Proposed by Seo Jeong-suk, IMD's regulatory bill is also needed

There is a consensus on the problems of drugs distributed in Korea


Following Binex, Vivozon illegally manufactured medicines in violation of the Pharmaceutical Affairs Act. As a result, the '1+3 Regulation Act' legislation that directly limits the number of drug became valid.

The reason was the domestic licensing system and regulatory environment in which too many generics could obtain marketing licenses. Vivozon's incident made ¡®1+3 Regulation Act¡¯ even more necessary.

According to the National Assembly and pharmaceutical industry officials on the 12th, Binex and Vivozon incidents further necessitated a legislative 1+3 Regulation Act for generics and data submission drugs.

1+3 Regulation Act was proposed by Rep. Yeong-Seok Seo (Democrat

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