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  • Collaboration on Development of Standards to Improve Dietary Supplements & Herbal Medicines Quality

    Nam-Cheol Kim, Ph.D.

    Scientific Liaison

    Dietary Supplements and Herbal Medicines

    United States Pharmacopeia

  • Content

     BDSHM Quality

     USP DSHM Program

     Collaboration and Opportunities

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    © 2018 USP

  • 3

    © 2018 USP

    Sources: The New York Times, Feb 3, 2015; The Korean Broadcasting System (KBS) Company News, Jun 24, 2015

    Common Concerns (and Issues)

    Supplement containing Cynanchum wilfordii (백수오) contaminated with Cynanchum auriculatum (이엽우피소)

     Utilized DNA method

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    © 2018 USP

    What We Should Consider…

     Standardized nomenclature is essential. DNA-based

    identification methods may be used as one of the aids to

    identify organisms

     Use orthogonal chemical methods to complement the DNA-

    based methods for establishing the identity and quality of the

    ingredient

     DNA-based methods help to support identification of botanical

    articles

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    © 2018 USP

     Specifications and quality controls are required for registration and international commerce

     Public standards

    – Set by independent experts using a robust, transparent process that involves the evaluation and

    incorporation of public comments

    – Expertise drawn from diverse sectors, including academia, industry, and regulatory bodies

    – Standards based on the development and submission of robust data

    – Public standards intended to meet the need of different manufacturers, regulators, multiple suppliers,

    practitioners and consumers

     Availability of public specifications that can be freely adopted and/or adapted would facilitate public health

    and safety

    Value of Public Quality Standards

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    © 2018 USP

    https://hmc.usp.org

    USP Dietary Supplements & Herbal Medicines Compendia

    USP Dietary Supplements Compendium

     75 new dietary supplement monographs--nearly 500 in

    all--from USP 38-NF 33 through the First Supplement

     27 new General Chapters

     More than 175 excipient (NF) monographs

     Over 200 Food Chemicals Codex (FCC) monographs

     More than 40 new and revised DSC admission

    evaluations

     Includes over 150 added pages of color plates and

    illustrations

    https://online.uspdsc.com

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    © 2018 USP

    USP Reference Standards- A Benchmark for Quality

     Trusted for quality control worldwide

     Over 3,600 Reference Standards now

    available

     Support standards and tests in various

    USP compendia

     Highly pure, with purity values

    provided for quantitative standards

     Korea is high rank in USP RS sales

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    © 2018 USP

    USP Verification Services Adulteration of Dietary Supplements

    Programs to Ensure DSHM Quality

     Focus on categories of products marketed for

    sexual enhancement, weight loss, and sport

    bodybuilding

     To develop screening methods for drugs as

    adulterants for dietary supplements based on

    the claimed benefits and similar drug effects

    of such adulterants

     USP Workshops on DS and Food Adulteration

    (2011–2015)

     USP Expert Panel on Adulteration (July 2013–

    Present)

     USP General Chapter “Screening for

    Undeclared Drugs and Drug Analogues”

     Roman Database (USP Adulteration

    Database)

     Annually evaluate quality of verified products through:

    – Good Manufacturing Practice (GMP) facility audits

    – Product quality control & manufacturing process evaluation

    – Product testing

     https://www.usp.org/services/verification-services

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    © 2018 USP

     USP’s HMC East Asia Expert Panel member (Professor Yeong Shik Kim, SNU)

     Standard co-development with Herbal Medicines Research Division in NIFDS

     Dialog with Health Functional Food Policy Division in MFDS

     Invitation by Korean Health Supplements Association

    Collaboration with Korea for Herbal Medicines

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    © 2018 USP

     USP and NIFDS has MOU since 2012 (renewed in 2015 and 2018)

     Progress in Workplan

    – Monograph and RS co-development underway for six Korean TM-based plants (including Angelica

    gigas Root)

    – Visiting Scientist through Executive Exchange Program

    – Formed Working Group (April 2019)

     Other ways of working with NIFDS HM through:

    – Forum for Harmonization of Herbal Medicines (FHH): NIFDS (member) and USP (observer) jointly

    proposed harmonized reference standard developments

    – WHO/WPRO: USP was invited as an instructor in NIFDS funded HM training course in Vietnam

    Milestone with NIFDS HM

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    © 2018 USP

    Fingerprint of Danggui Species

    Standards

    1. chlorogenic acid, 2. ferulic acid, 3. nodakenin, 4. decursinol, 5.

    xanthotoxin, 6. coniferyl ferulate, 7. demethylsuberosin, 8. Z-ligustilide,

    9. decursin, 10. decursinol angelate, I.S. a-asarone

    A. gigas

    A. sinensis

    A. acutiloba

    A. gigas A. gigas

    Standard

     The differences between three Danggui species indicates the possibility of needs for separate standards using harmonized methods

    Species Country

    Angelica sinensis China

    Angelica gigas Korea

    Angelica acutiloba Vietnam/Japan

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    © 2018 USP

     Prioritize Korean herbal materials for KP-USP standard co-development

    (monographs and reference standards)

     Research the gaps for potential harmonization including specifications and test

    methods

     Facilitate visiting program

     Engage with more companies that are interested in and can contribute to HM

    and BDS standard developments

     Encourage participation in USP Expert Committees

    Potential Future Plans

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    © 2018 USP

    Call for Candidates

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