http://www.mfds.go.kr/index.do  是韩语的 韩药监局网站；

http://www.mfds.go.kr/eng/index.do?nMenuCode=126  

英语版的网站  也能看到   DRUGS -- Approval Proces

Regulations  中可以看到：

Regulation on Designation of Valid Period for Pharmaceuticals Approval and Notification

Regulation on Pharmaceutical GMP

Designation of Pharmaceuticals Required securing Pharmaceutical Equivalence

Regulation on Pharmacology Study for Pharmaceutical Drugs, etc

Standard on Bioequivalence Study Management