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KMID : 0363620120330030147
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Journal of Korean Oriental Medicine
2012 Volume.33 No. 3 p.147 ~ p.159
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A Comparative Analysis of the Systems Related to the Production, Authorization, and Listing for Insurance of Herbal Medicine Products in South Korea and Taiw
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Son Chi-Hyoung
Lim Sabina
Lee Eun-Kyoung
Kim Dong-Su
Kim Yun-Ji
Cheng Huna-Chiang
Kim Yong-Ho
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Abstract
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Objectives: Systems related to the production, authorization, and listing for insurance of herbal medicine products were compared between South Korea and Taiwan to illuminate herbal medicine products system issues in South Korea.
Methods: Papers, and laws and policies related to the production, authorization, and listing for insurance of herbal medicine products in South Korea and Taiwan are analyzed to create the primary documents. The documents from South Korea were screened with the advice of a specialist, while those from Taiwan have been verified through local investigation and with the help of a related specialist. The screened documents were then compared and analyzed in the order of the systems related to the production, authorization, and listing for insurance of herbal medicine products.
Results: The systems related to the production of herbal medicine products satisfy GMP requirements in both countries, while Taiwan has more specialized systems related to the production of herbal medicine products and a more strict authorization program as compared to South Korea. While South Korea has most of the herbal medicine products classified as non-prescription drugs, Taiwan has them as prescription drugs. And while South Korea does not allow new herbal medicine products to be listed for insurance, Taiwan allows for once-a-year application toward listing for insurance.
Conclusions: In order to ensure the safe and effective use of herbal medicine products, systems related to the production, authorization, and listing for insurance of herbal medicine products are to be established, while the categorization of medicine products principally used by Korean medicine doctors should be prepared. Furthermore, prescription by a Korean medicine doctor for new drugs made with natural products and their listing for insurance need to be encouraged.
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