Immunotoxicity Evaluation and Guidelines for Drug Approval in Korea

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.