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KMID : 0861120140180010023
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Korean Journal of Oriental Preventive Medicine
2014 Volume.18 No. 1 p.23 ~ p.41
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A Study on the Changes in Legal Definition of Medicinal Products in the Relevant Laws and Regulations
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Eom Seok-Ki
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Abstract
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Objective : The purpose of this study was to lay the groundwork for understanding the details and scopeof the legal definition of medicinal products, following the changes in the relevant laws and regulations. This will let readers properly understand the origins of the ongoing conflicts on herbal drugs and newdrugs from natural products that are present in the medical field and the medical industry. Possible solutionsare proposed in the end.
Method : I analyzed the changes in definition of medicinal products since 1945 that have been used inrelevant laws and regulations(i.e. Pharmaceutical Affairs Act) and drug approval process(i.e. New DrugApplication and Investigational New Drug Application).
Results : Legal definition of medicinal products has changed in accordance with the changes in the pharmaceuticalindustry, such as the establishment of dualistic medical and pharmaceutical System and theintroduction of the substance patent. Due to those changes, boundaries of Western medicinal products andhealth food expanded, while those of herbal medicine products relatively downscaled.
Conclusion : Legal definition of medicinal products-i.e. Herbal Drugs, Crude Drugs, and New Drugs fromNatural Products-should be reestablished according to academic legitimacy and dualistic medical and pharmaceuticalSystem.
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KEYWORD
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herbal drug, crude drug, natural product, Herbal medicinal preparations, Crude drug preparations, Natural product new drug
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