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Korean Pharmacopoeia

Mission

The Korean Pharmacopoeia is a statute for pharmaceuticals established by Korean government for improvement of public health. KP is served as the characteristics of official standard for the description and quality of drugs which are generally recognized to be safe and efficacious in the treatment and prevention of diseases and its role should be to specify the standards of drugs in preparation, identification, efficacy, quality and storage.

History

Pursuant to Provision of Article 51 of Pharmaceutical Affairs Act, the Korean Pharmacopeia(Korean version, hereinafter to as the KP), a statute for pharmaceuticals to improve public health, was first established on Oct. 10, 1958 and the second edition published in 1967 and third in 1976. Since then, the KP has been revised in every 5-years term, the 11th edition was published in 2014.

 

Revision Edition
Revision Edition Revision Date Total No. of monographs
KP   1958.10.10. 632
KP   1967.10.10. 1182
  Supplement 1 1968. 8.29. -
  Supplement 2 1969. 5.28. -
  Supplement 3 1972. 1.24. -
KP   1976.12.10. 1,013
  Supplement 1 1978. 2. 1. 1,159
  Supplement 2 1979. 1.13. 1,231
KP   1982. 3. 1. 1,212
  Supplement 1 1982.11.24. -
KP   1987. 4.22. 1,308
  Supplement 1 1988. 3.16. 1,316
KP   1992. 4. 7. 1,428
  Supplement 1 1993. 3.26. 1,428
KP   1997.12.31. 1,482
  Supplement 1 2000. 2.19. 1,482
KP   2002.12.30. 1,485
  Supplement 1 2006. 7.24. 1,462
KP   2007.12.28. 1,511
  Supplement 1 2009. 7. 9. 1,511
  Supplement 2 2010. 2. 24 1,526
  Supplement 3 2010. 5. 3. 1,526
  Supplement 4 2010. 5. 28 1,649
  Supplement 5 2010. 12. 31 1,718
  Supplement 6 2011. 3. 14 1,718
  Supplement 7 2011. 10. 28 1,716
  Supplement 8 2012. 3. 26 1,717
KP X   2012.12.27 1,559
KP XI   2014. 12. 5 2,462

The five principles of establishment and revision for KP are

  • 1.To include all drugs which are relevant from the viewpoint of health care and medical treatment
  • 2.To revise in timely fashion in part, if necessary, for efficient application
  • 3.To follow international harmonization
  • 4.To ensure transparency regarding the revision of the KP and render the document publically available
  • 5.To include up-to-date analytical methods in timely fashion and prepare reference standards

Revision Process

  • Establishment of the guideline on KPs revision
  • Collecting scientific data through R&D
  • Monitoring foreign pharmacopoeias revision, international trend of globalization of pharmacopoeias by the international harmonization organization
  • Hearing/Converging opinions from pharmaceutical industries
  • Collecting and reviewing data
  • Selecting provisions or sections which need to be revised
  • Setting draft of revised Korean pharmacopoeia
  • Producing final draft for revision
  • Releasing the draft for public comments
  • Deliberation on the draft by central pharmaceutical affairs council
  • Promulgating the revision by the commissioner of KFDA after public notice
  • Publication of revised Korean pharmacopoeia

Departmental Role

Pharmaceutical Standardization on Research and testing Division

  • Provide specifications based on scientific data through R&D
  • Provide draft for revision through the development of test methods

R & D

  • Monitor and develop test methods

Pharmaceutical Standardization Division

  • Establish plans and guidelines for the revision
  • Comprehensively review scientific data and draft through R&D and monitor recent information on specifications from foreign countries and international organizations
  • Provide draft for revision
  • Release draft for public comments
  • Review and confirm draft and final revision

Pharmaceutical Industry and Academia

  • Collect opinions from industry, academia and research

Pharmaceutical Safety Policy Division

  • Establish basic policy for specifications
  • Propose deliberation to central pharmaceutical affairs council for revision
  • Promulgate Korean Pharmacopoeia after public notice

Contents

THE KOREAN PHARMACOPOELA Notification General Notices General Requirements for Pharmaceutical Preparations Monograph, Part  (A ~ I) Monograph, Part  (J ~ Z) Monograph, Part General Tests General Information