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KMID : 1138720170430010039
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Korean Public Health Research
2017 Volume.43 No. 1 p.39 ~ p.51
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Establishing Good Safety and Effectiveness Evaluation System for Globalization of Herbal Medicines
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Park Kyoung-Hoon
Lee Joong-yub
Choi Hyun-Jin
Park Byung-Joo
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Abstract
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In order to globalize the herbal medicines, it is necessary to go through the drug approval process of evaluating safety and efficacy of new drug candidates. The US Food and Drug Administration (FDA) requests evidence on safety and efficacy of new drug candidates based on the data from preclinical experiments, Phase 1 trials, Phase 2 trials, and Phase 3 trials for getting approval for marketing. In addition to the preapproval clinical trials data, in recent years, US FDA also requires a post-marketing study or Phase 4 trials data for guaranteeing safety of the newly marketed drugs. In Korea, legally, traditional herbal medicines were not necessary to go through the formal drug approval process before using them to patients. We analyzed studies of Joins Tab (Clematidis Radix, Trichosanthes Root, Prunella Spike 30% Ethanol Extracts), which extracted traditional herbal medicines have been approved from KFDA based on the preapproval clinical trial data in Korea. The revision of the relevant laws for traditional herbal medicines should be needed to follow the formal new drug approval process for the Western medicines for providing more safe and effective medicines to patients.
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KEYWORD
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Herbal medicine, Globalization, Safety, Efficacy, Post-marketing study
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