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.
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. 1999–60, revised on December 22, 1999).
5.
Guidelines for Toxicity Studies of Drugs (Korea Food and Drug Administration Notification No. 1999–61, revised on December 22, 1999).
6.
KimYOChungHJParkJHKimDSChoDHImmunotoxicity evaluation and guidelines for drug approval in Korea. Drug Inf J.2000;34:25–32.
