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Herbal/Korean Traditional Products

Review & Approval

Background

  • To develop an advanced system for the review and approval of Korean traditional (herbal) products in response to the progress of pharmaceutical development technologies

Key activities

  • Review of the quality, safety, efficacy, pharmaceutical equivalence and clinical study protocols of Korean traditional (herbal) products
  • Development of standards for quality review of Korean traditional (herbal) products
  • Establishment of specifications for Korean traditional (herbal) products
  • Development of guidelines for the review and assessment of Korean traditional (herbal) products
  • Supports for the commercialization of Korean traditional (herbal) products
R&D
Reinforced safety control of Korean traditional(herbal) products, quality assurance of herbal reference standards and proactive responses to international harmonization and trends to ensure competitiveness
1 Reinforced safety control of Korean traditional(herbal) products
  • Development of new methods for quality assessment of Korean traditional(herbal) products
  • Risk assessment and monitoring of hazardous substances, such as residues and contaminants
  • Development of specifications and analytical procedures(such as identification tests)
2 Quality assurance and international harmonization of herbal reference standards
  • Continuous preparation and supply of quality-assured herbal reference standards
  • International cooperation to ensure internationally harmonized herbal standards
3 Proactive responses to international trends to ensure competitiveness
  • Systematic resources management to prepare for the Nagoya Protocol
  • Active participation in international standardization (ISO/TC249)
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