• Title/Summary/Keyword: ISO 11238

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Review of Identification of Medicinal Products (IDMP) Standards for Standardization of Herbal Medicine Information (한약 정보 표준화를 위한 의약품 식별 표준 (IDMP) 분석 및 고찰)

  • Kim, Young-Sik;Kim, Anna;Lee, Seungho
    • The Korea Journal of Herbology
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    • v.37 no.5
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    • pp.37-51
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    • 2022
  • Objectives : The purpose of this study was to apply informations related to herbal medicines to IDMP (Identification of Medicinal Products), an ISO standards related to medicinal products substances, for systematic collection of data through the integration of informations on distribution, manufacturing, and management of herbal medicines. Methods : By analyzing ISO 11238 and ISO/TS 19844, elements that can be used in the information model of herbal medicine were derived from the identification of medicinal products information model on substances. The labeling specified in the safety and quality control regulations for herbal medicines was mapped to the IDMP information model, and ginseng was applied as an example. Results : Herbal medicine corresponded to substance in IDMP. Among the five types of substances specified by IDMP, herbal medicines were expressed as structurally diverse. Scientific name was used as an invariant property of herbal medicine, and the substance level included information about source material and modification, and specifically included information about the scientific name, medicinal part, fraction, and processing. In addition, the specified substance level had information on the constituents, characteristic attributes, manufacturing, and grade of the herbal medicine. Conclusions : It is necessary to establish a code system for identifying herbal medicines. In order to apply the IDMP standards, research on the development of standard terms is required to express the characteristics of herbal medicines. In addition, information for identification of herbal medicines is also required, and information from production to consumption should be systematically accumulated and managed for actual application.