Current Drug Regulatory Status of Advanced Drug Evaluation System in Korea
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Current Drug Regulatory Status of Advanced Drug Evaluation System in Korea
In-Sook Park, PhD Deputy Director. Pharmaceutical Standardization and Cardiovascular Drug Division. Drug Evaluation Department. Korea Food and Drug Administration. Seoul, Korea
Dong Sup Kim, PhD Director General. Toxicological Research Department. National Institute of Toxicological Research, Korea Food and Drug Administration. Seoul, Korea
The pharmaceutical industry is a high-risk and high value-added ni-, because the risk of failure in research and development is considerable. Howeve successjid development will allow a company to get high retunts. The market scale of the pharmaceutical industry has been increasing in the wdd and the Korean market is changing to focus on quality of life drugs owing to people’s increased income levels and changing Iifes@es. Drug products are important for the prevention, diagnosis, and treatment of diseases, and the development of drug products has resulted in improved quality of life, health maintenance, and considemblebenefits to individuals as well as the national economy Howeve since drug products carry the risks of adverse reactions,
Key Words Korea; KFDA; Drug approval; GRP: CTD: G M P : I N D
Correspondence Address Dong Sup Kim. PhD, Toxicological Research Department. National Institute of Toxicological Research, Korea Food and Drug Administration, 194 Tongiro, Eunpyeong-gu, Seoul, 122-704.Republic of Korea (email: [email protected]. kr).
I NTR 0 D U C T I 0 N The present Korea Food and Drug Administration (KFDA) was established in 1998 after several changes. The ultimate goal of KFDA is to improve the health status of the people by minimizing the risks associated with the usage of medical products and consumption of food. The Pharmaceutical Safety Bureau is responsible for developing comprehensive safety management plans for drugs, quasi-drugs, and cosmetics. There have been several drug regulatory changes since the Korea Good Manufacturing Practice (KGMP) standard was established in 1977. These have been affected mainly by International Conference on Harmonization (ICH) guidelines. Recently, one of the major issues in pharmaceutical industry and drug regulation has been the signing of the Korea-US Free Trade Agreement (Fw. The signing of the Korea-US FTA will internationalize the environment for the pharmaceutical industry. It is necessary to prepare for the sale of drug products developed in Korea in more developed countries, reinforcing the in-
they have to satisjj the two important criteria of safety and efficacu. fierejbre, the Korean gavemment has implemented a drug safety management system, including one for autholization ofdrugpromccts. h e n @ , one ofthc most important issues in the h n pharmaceutical industry has been the signing of the Korea-US FlA (Free Tmde Agreement), which will promote rapid and widespread competition. The pharmaceutical industry will also face the challenges of a more competitive environment. For sustainable growth and development of the Korean pharmaceutica
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