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Strategic Development Plan of Standardization on Korean Medicine: Comparison with Traditional Medicine Policies between Korea and China

Article information

J Korean Med. 2016;37(3):97-111
Publication date (electronic) : 2016 September 30
doi : https://doi.org/10.13048/jkm.16038
Juyeon Lee1, Minho Lee1, Sun-mi Choi1, Yong-suk Kim2, Byunghee Koh2, Jinseok Moon1,
1Korean Medicine Standards Center, Korea Institute of Oriental Medicine
2Department of Korean Medicine, Kyunghee University
Correspondence to: 문진석 (Jinseok Moon), 대전 유성구 유성대로 1672 한국한의학연구원, Tel: +82-42-868-9595, Fax: +82-42-869-2703, E-mail: moonstone2@kiom.re.kr
Received 2016 July 27; Revised 2016 September 29; Accepted 2016 September 29.

Abstract

Objectives

This study aims to investigate the policy status of traditional medicine standardization between Korea and China as well as to derive a strategic development plan for Korean medicine standardization.

Methods

The existing national plans and preceding studies on traditional medicine standardization in Korea and China were reviewed, and scope of the study was categorized as having three main aspects: infrastructure; standard development and standardization activities; and application and diffusion.

Results

Nine development plans for Korean medicine standardization derived under the study were as follows: With regard to infrastructure of standardization, 1) standardization plan of Korean medicine shall be established based on involvement of multi-government ministries. 2) It shall be set with a consistent cooperation process among standardization-related organizations, as well as 3) encourage the industry to participate in standardization activities. To activate standards development, 4) launching the R&D-standardization-industrialization linked project, 5) supporting Korean medicine society and the mirror committee for motivation, and 6) planning the international joint research for development of standard and expanding standardization activities are recommended. In the aspect of application, there is a need for 7) expanding certification systems for the industry and 8) evaluation and feedback on the life-cycle of standardization. Lastly, 9) educational programs for training experts of standardization shall be developed and implemented.

Conclusions

In order to invigorate standardization activities for Korean medicine, enhancement of planning and evaluation capacity, ensuring the strategic development of standards, broadening boundaries of international standardization activities, and training professionals are required.

Keywords: Korean medicine; Standardization; Development plan; Infrastructure

The Main Scope of the Existing Standardization Strategies in Korea and China

Classification for Analyzing Current Status of Standardization on Traditional Medicine(TM)

Korean-Chinese Traditional Medicine Standardization Laws and Plan

Korean-Chinese Organizations Related with Traditional Medicine Standardization

Standard Development Field on Korean-Chinese Traditional Medicine Standardization Plan

The Number of International Standard Proposals by Country

References

1. Korea Institute of Oriental Medicine. International forum on Future Direction of Traditional Medicine Standardization 2008.
2. Wang Y, Wang ZG, Han XJ, Li YY, Liu Y, He Y. The Urgency of Establishing the Technical Standard System of Traditional Chinese Medicine. Journal of Traditional Chinese Medicine 2007;48(6):557–559.
3. Korean Standards Association. The Status and study of The National Standards Strategy. Issue paper 2015. p. 2.
4. Ministry of Health and Welfare. The Act on the Promotion of Korean Medicine and Pharmaceuticals 2012. Chapter 2.1 & Chapter 2.2
5. KS A ISO/IEC Guide 22002.
6. Wang L, Han X, Yu W, Shi N, Lv A. Several Suggestions on the Promotion of TCM Standardization. World Science and Technology (Modernization of Traditional Chinese Medicine and Materia Medical 2011;:4.
7. Zhao Z, Deng WP, Chang K, Wang M. Discussion on the Construction of Standardized Experts in Traditional Chinese Medicine. Journal of Traditional Chinese Medicine Management 2011;(4)
8. Ko CR, Ku NP, Seol SS. A Comparative Study on the Traditional Medicine Policies between Korea and China: Focused on the Second Korean Medicine Development Plan and the 12·5 Traditional Chinese Medicine Development Plan. Journal of Korea Technology Innovation Society 2014;17(2):421–447.
9. Lee UY. Chinese Preempting Strategy for The World Standard of The Oriental Medicine and the Counter Strategy of The Korean Medicine 2012.
10. Korea Institute of Oriental Medicine. Korean Medicine Standardization Strategy Map (2015–2024) 2014. p. 32.
11. Korea Institute of Oriental Medicine. Framework on Standardization of Korean Medicine 2012. p. 151–164.
12. Ministry of Health & Welfare. the 3rd Korean Medicine Promotion and Development Plan (2016–2020) 2016.
13. Ministry of Trade, Industry and Energy. The 4th Framework Plan of National Standards 2016.
14. National Science & Technology Information Service. Available at: URL:http://www.ntis.go.kr.
15. China News of Traditional Chinese Medicine. The key of Traditional Chinese Medicine standardization implementation is manpower Available at: URL: http://paper.cntcm.com.cn/html/content/2016-02/26/node_2.htm. Accessed October 22, 2014.
16. WHO. WHO International Standard Terminologies on Traditional Medicine in the Western Pacific Region; 2007.
17. WHO. WHO Standard acupuncture point locations in the western pacific region 2008.
18. WHO. The International Classification of Diseases 11th Revision is due by 2018 Available at: URL: http://www.who.int/classifications/icd/revision/en/.
19. Korea Bio-Economy Research Center. 2014 Biopharmaceutics Trend Report 2014. p. 9.
20. Zhen Z. Acupuncture in Australia: regulation, education, practice, and research. Integr Med Res 2014;3(3):103–110.
21. Ministry of Food and Drug Safety. 2015 Food & Drug Statistical Yearbook 2015. p. 381.
22. European Medicines Agency-Committee on Herbal Medicinal Products. Available at: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000264.jsp.
23.

ISO/IEC Directives Part1. 2016

25. State Administration of Traditional Chinese Medicine. Evaluation criteria of 3 level Hospital of Traditional Chinese Medicine 2012.
26. Wang Z. Non-economic benefits of standards Shanghai Shuguang Hospital. China: ISO. 2014.
27. Korea Institute for Healthcare Accreditation. Available at: URL: http://www.koiha.kr/member/kr/certStatus/certList.do.
28. Ministry of Food and Drug Safety. The 3rd policy briefing of Medicinal herbs manufacturing for a manufacturer 2014.
29. Korea Institute of Oriental Medicine. Korean Medicine Standards Center Management Plan 2011.

Article information Continued

Copyright © 2016 The Society of Korean Medicine all rights reserved

Table 1

The Main Scope of the Existing Standardization Strategies in Korea and China

Korean Medicine(KM) Standardization Strategy Roadmap Traditional Chinese Medicine(TKM) Standardization Long-term Development Plan

  • Establishment and Planning for Law, System, Program

  • Roadmap and action plan

  • Support Policy and Establishment System

  • Establishment Evaluation System

  • Proposal International Standards

  • Management of Expert Committee

  • International Standardization Projects

  • Establishment Committee for TKM Standardization

  • Performance Standardization Researches

  • Performance Standardization Researches

  • Construction DB and Diffusion of Standardization

  • Support Forum for Standardization

  • Construction Information Platform

  • Application and Diffusion of TKM Standard

  • Reinforcement Integrated Resource

  • Training Experts

  • Organization Standardization Expert Groups

Table 2

Classification for Analyzing Current Status of Standardization on Traditional Medicine(TM)

Main Category Subcategory Contents
Infrastructure of Standardization Standardization Policy

  • Law and Acts related with KM and Standard

  • System and Plan
Organization/Institution

  • Governments, Association, Society, Industries, etc.

  • Management Mirror Committee
Planning for Standard Development

  • Establishment Long-term Standardization Strategy

  • Discovery Standardization Item and Planning Projects
Standard Development and Activities R&D and Budget

  • Performance Standardization R&D

  • Connection with R&D-Standardization-Industrialization
Activities for Standardization

  • Activities of Proposal and Coping with Standard

  • Activities of Convener, Secretariat, Project leaders, etc.
International Cooperation

  • Collaboration with International Organization

  • Cooperation between Nations
Application and Dissemination Certification

  • Certification for Products in KM

  • Certification of Service and Hospitals
Performance Evaluation

  • Evaluation Whole Standardization Process
Training and Dissemination

  • Training for Human Resources

  • Dissemination Standards and Providing Information

Table 3

Korean-Chinese Traditional Medicine Standardization Laws and Plan

Korea China
Traditional Medicine related Acts and Plan

  • ⌈ACT ON THE PROMOTION OF KOREAN MEDICINE AND PHARMACEUTICALS⌋

  • ⌈The 2nd Korean Medicine Promotion and Development Plan (2011–2015)⌋

  • ⌈The 3rd Korean Medicine Promotion and Development Plan (2016–2020) ⌋

  • ⌈Act on Traditional Chinese Medicine⌋ (pre-announcement of legislation)

  • ⌈The 12·5 Traditional Chinese Medicine Development Plan⌋

  • ⌈The 13·5 Traditional Chinese Medicine Development Plan⌋
Standardization of Traditional Medicine related Acts and Plans

  • ⌈The 4th Framework Plan of National Standards⌋

  • ⌈The Development Plan for TKM Standardization(2006–2010)⌋

  • ⌈TKM Standardization Long-term Development Plan (2011–2020)⌋

Table 4

Korean-Chinese Organizations Related with Traditional Medicine Standardization

Korea China
ISO Member Body Korean Agency for Technology and Standards(KATS) Standardization Administration of China(SAC)
Competent Ministry in charge of Standardization of Traditional Medicine Ministry of Food and Drug Safety Ministry of Health and Welfare State Administration of Traditional Chinese Medicine
ISO/TC249 Mirror Committee KM Standards Center, Korea Institute of Oriental Medicine Institute of Clinical Basic Medicine, China Academy of Chinese Medical Sciences

Table 5

Standard Development Field on Korean-Chinese Traditional Medicine Standardization Plan

Korean Medicine(KM) Standardization Strategy Roadmap Traditional Chinese Medicine(TKM) Standardization Long-term Development Plan
Terminology and Medical Informatics Basic Standards(Terminology and Informatics)
Herbal Raw Material and Herbal Products Herbal Medicine
Medical Devices Acupuncture Needles and Moxibustion devices
KM Services Medical Treatment Manipulation for Acupuncture and Moxibustion Preventive Treatment Disease Health Care Management System
- Training Management Scientific Research Management Ethnic Medicine

Table 6

The Number of International Standard Proposals by Country

Fields Korea China Other countries
Herbal Medicine 5 15 4
Medical Device 11 14 6
Terminology and Informatics - 9 -