USP Dietary Supplements & Herbal Medicines...USP Dietary Supplements & Herbal Medicines Compendia...

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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

Transcript of USP Dietary Supplements & Herbal Medicines...USP Dietary Supplements & Herbal Medicines Compendia...

Page 1: USP Dietary Supplements & Herbal Medicines...USP Dietary Supplements & Herbal Medicines Compendia USP Dietary Supplements Compendium 75 new dietary supplement monographs--nearly 500

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

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Content

BDSHM Quality

USP DSHM Program

Collaboration and Opportunities

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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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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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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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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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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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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 <2251> “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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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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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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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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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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Call for Candidates

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