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KFDA announced in advance revised draft for drug safety and efficacy evaluation guidelines.

Published: 1999-06-01 17:06:00
Updated: 1999-06-01 17:06:00
The KFDA announced in advance the revised draft for "the working rules of drug safety and efficacy evaluation" as of May 31.

According to the new provisions, the health registration of the new drug developed overseas does not require a domestic clinical phase III study from July 1 this year, instead, replacing with a bridging study system for scientific and rational confirmation on the safe...

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