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JKM > Volume 37(3); 2016 > Article
Lee, Lee, Choi, Kim, Koh, and Moon: Strategic Development Plan of Standardization on Korean Medicine: Comparison with Traditional Medicine Policies between Korea and China

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.

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 -

참고문헌

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