Abstract
Current drug regulation in Korea is based on the Pharmaceutical Affairs Law, which was revised 14 times. Immunotoxicity guidelines are described in the “Regulation for Evaluation on Safety and Efficacy of Drugs” (Korea Food and Drug Administration Notification No. 1999–13, revised on February 6, 1999) and “Guidelines for Toxicity Studies of Drugs” (Korea Food and Drug Administration Notification No. 1998–116). This paper describes the review process and immunotoxicity guidelines for drug approval in Korea.
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References
1.Pharmaceutical Affairs Law (Law No. 5959, revised on March 31, 1999 ).
2.Enforcement Regulation of the Law (Ministry of Health and Welfare Ordinance No. 92, revised on January 6, 1999 ).
3.Guidelines for Application Form for Approval (Notification) of Manufacturer and Manufacture (Import) of Drugs (Korea Food and Drug Administration Notification No. 1998–129, revised on December 31, 1998 ).
4.Regulation for Evaluation on Safety and Efficacy of Drugs (Korea Food and Drug Administration Notification No. 1999–13, revised on February 6, 1999 ).
5.Guidelines for Toxicity Studies of Drugs (Korea Food and Drug Administration Notification No. 1998–116, revised on December 3, 1998 ).