Safety Evaluation for New Drug Approval in Korea

Current drug regulation in Korea is based on the Pharmaceutical Affairs Law, which has been revised 14 times. Toxicity guidelines are described in the Regulation for Evaluation on Safety and Efficacy of Drugs (Korea Food and Drug Administration Notification No. 1999–60, revised on December 22, 1999) and Guidelines for Toxicity Studies of Drugs (Korea Food and Drug Administration Notification No. 1999–61, revised on December 22, 1999). This paper describes the review process and toxicity guidelines for new drug approval in Korea.