Safety Evaluation for New Drug Approval in Korea
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0092-8615/2001 Copyright 0 2001 Drug Information Association Inc.
SAFETY EVALUATION FOR NEW DRUG APPROVAL IN KOREA Y O U N G - O K KIM,
PHD
Senior Researcher, General Toxicology Division
KWANG-WON HA, PHD Director, Toxicology Department
KWANG-SIK CHOI,PHD Chief, General Toxicology Division National Institute of Toxicological Research, Korea Food & Drug Administration, Seoul, 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 Notifcation No. 1999-61, revised on December 22, 1999). This paper describes the review process and toxicity guidelines for new drug approval in Korea. Key Words: Toxicity guidelines; Korea; New drug approval
INTRODUCTION KOREA IS AN IMPORTANT country in terms of production and consumption of medicines. In 1999, pharmaceutical production in Korea totalled $7 billion. Recently, a new molecular entity was developed by a Korean pharmaceutical company. Through November 1999, 127 new drugs were under development in Korea. One product has been approved, 22 are currently undergoing clinical tests, 33 are undergoing preclinical tests, and 71 are undergoing screening. An anticancer drug was approved by the Korea Food and Drug Administration (KFDA) in July 1999 and has been marketed. It is a platinum complex salt for stomach cancer. In addition,
many crude drugs have been approved and marketed in Korea. From the viewpoint of pharmaceutical companies, the regulatory systems that currently exist in Korea are not as transparent as their counterparts in the Western Hemisphere. However, in comparison to the United States, European Union, and Japan, there appears to be far less regulatory information published and available for use by pharmaceutical companies. There also appears to be much less opportunity for dialogue between the industry and the regulatory bodies. This manuscript provides regulatory information for foreign pharmaceutical companies.
HISTORY OF TOXICITY GUIDELINES FOR NEW DRUG APPROVAL
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Reprint address: Young-Ok Kim, Senior Researcher, General Toxicology Division, National Institute of Toxicological Research, Korea Food & Drug Administration, Nokbun-Dong, Eunpyung-Ku, Seoul, 122-704, Korea. E-mail: youngok0kfda.go.h.
The law applicable to development and regulation of drugs and pharmaceutical adminis-
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Young-Ok Kim, Kwang-Won Ha, and Kwang-Sik Choi
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tration, the Pharmaceutical Affairs Law, was first enacted in 1953. It has been revised 14 times, most recently in March 1999. The primary regulations and guidelines applicable for drug development include the following: Enforcement Regulation of the Law (Ministry of Health and Welfare Ordinance No. 92, revised on
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