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KFDA to exempt safety test of generic drugs.

Published: 2005-11-02 06:58:00
Updated: 2005-11-02 06:58:00
The KFDA disclosed the draft of partial revised test standards of drug safety on Oct. 27, which harmonized with, an international ICH guideline and newly established exempted cases of the test and the evaluation thereof.

Accordingly, the same preparations in terms of its active substances and dosage forms may not require a safety test (except the biological preparations), and the registrati...

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