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Revised examination regulations for drug safety and efficacy launched from Dec. 22.

Published: 1999-12-27 17:02:00
Updated: 1999-12-27 17:02:00
As of Dec. 22 the bridge study system takes effect for evaluation of foreign clinical data which was recommended by ICH as one of scientifical and rational evaluation approaches for drug efficacy and safety of Korean patients in return of abolishing the current registration requirements of domestic clinical phase III study obligation for a new drug originated from overseas.

The KFDA official...

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