Ⅰ
Ⅲ
Ⅰ
KP Edition Revision Date English Version Monographs
First Edition 10 OCT 1958 632
Second Edition 10 OCT 1967 1,182
Third Edition 10 DEC 1976 1,013
Fourth Edition 01 MAY 1982 1,212
Fifth Edition 22 APRIL 1987 1,308
Sixth Edition 07 APRIL 1992 1,428
Seventh Edition 31 DEC 1997 1998 1,482
Eighth Edition 30 DED 2002 2003 1,485
Ninth Edition 28 DEC 2007 28 DEC 2008 1,511
Tenth Edition 27 DEC 2012 18 NOV 2013 1,559
Eleventh Edition 05 DEC 2014 - 2,462
Twelfth Edition Scheduled in 2019 - -
Entire Revision of KP
Five-year cycle
- Recent entire revision of KP :
11th edition in 2014
Revision of the supplement of KP
Twice in a year
Formulate concrete plans for revision of
Korean Pharmacopoeia
Review new or revised items
Prepare a draft revision of Korean
Pharmacopoeia
Produce final draft of revised Korean
Pharmacopoeia
Solicit comments from Industry and Academia
Deliberation on revised Korean Pharmacopoeia by
Central pharmaceutical affairs review committee
Adopt revised Korean Pharmacopoeia
Work-flow
Planning and
Management
NIFDS
External
Cross check advisory
Experts
NIFDS regional branches Advising lab-test
lab institutes related issued
Performing
laboratory study to
develop test
methods
NIFDS labs
Academic labs
Pharmaceutical companies
11th Edition was promulgated on 5 DEC 2014.
General Notices
General Requirements for Preparations
Monographs
Part I : Frequently used drugs and primary preparations
Part II : Crude drugs, biological drugs, combined preparations,
additives for preparations and quasi-drug
General Tests, Processes and Apparatus
General Information
Index
KP 11th Edition
Monographs – Part I 2,009
Monographs – Part II 453
Herbal Drugs 179
Biological Drugs 49
Radioactive Drugs 28
Combined Preparations 19
Additives 162
Quasi Drugs 16
Total 2,462
Part I : Frequently used drugs and primary preparations
Part II : Crude drugs, biological drugs, combined preparations,
additives for preparations and quasi-drug.
Ⅱ
• Korean Pharmacopoeia Discussion Group in operation
`15 constantly (Pharmaceutical Standardization Division)
• 3-year plan for international harmonization of KP (Pharmaceutical
`16 Policy Division)
• Revising the manual of KP revision (Pharmaceutical Standardization
`17 Division)
• Roadmap for entire revision of KP (draft)
`18 (Drug Research Division, 2016-2018)
• Finalized KP 12TH edition (draft) (May 2019)
`19.5
`19
• Notification of the entire revision of KP (September 2019)
`19.9
Strengthen safety management based on new technologies
and improve user experience
Quality Innovation
Platform for high level of
quality assurance
To respond to the 4th industrial revolution,
Supporting drug development with
strengthen safety control and enhance
new technologies and enhancing regulatory flexibility
convenience/utilization
Test methods for new tech, more info on control
of manufacturing and quality
User-friendly Big Data
Providing KP in digital format based on DB
Electronic system will be user-friendly and provide more information
General Notices
• Introduction of QbD and control of impurities
and containers/packaging
General Requirements
for Pharmaceutical
• Inclusion of new criteria for performance
Preparations evaluation for each dosage form
Monographs
• Modernization of Specification and more
rigorous control of impurities
General Tests,
Processes and
• Reinforcement of safety management and
Apparatus inclusion of new test methods
General Information
• Provision of more information on manufacturing
and quality control
General
Notices
General
Requirements for
Pharmaceutical
Preparations
Monographs
Part 1
Monographs
Part 2
General Tests,
Processes and
Apparatus
General
Information
All year round public consultation
• Communicate with the public on the revision process of KP 12 on the MFDS
website
• Exclusive email for KP 12 as ‘Kopharm’ (
[email protected])
International Symposium for Revision of KP 12 (June 2019)
• Major purpose and changes for KP 12 and public consultation on site
• Future direction for KP and cases of foreign pharmacopoeias
Ⅲ
Stronger network with other
regulatory authorities
Support for trade of
pharmaceutical products in
cooperation with industry
Support for domestic
pharmaceutical products
• ICH (International Conference on Harmonization)
– Joined as ICH member (Nov 2016)
• PIC/S (Pharmaceutical Inspection Co-operation Scheme)
– Joined as PIC/S member (MAY 2014)
• WHO
– Participate in WHO Prequalification as Reviewer
– Prequalified 1 API, 3 FPP(chemicals), 17 Vaccines (Jun. 2017)
• IPRP (International Pharmaceutical Regulatros Programme)
– Joined as IGDRP(now IPRP) member (OCT 2011)
Q3D
• Implemented in Korea
Q3C
• Joined EWG
• Q3C(R8) Step 1
Q12
• Joined EWG
• Step 3
Q13
• Joined EWG
• Step 1
Purpose :
- Regulatory harmonization of generic drug review criteria
- Establishing cooperative system for generic drug review
- Strengthening proficiency of reviewers and review system
- Strengthening cooperative system for information sharing among
regulators
Achievement :
- Continuously joining the program since the 1st meeting
- Established cooperative system i.e. networks with RA experts
- Working Group activities: DMF Working Group and Biowaivers Working
Group
Sending MFDS experts for PQ assessment, as requested by WHO
- 2012 : 1 expert (bioequivalence)
- 2014 : 2 experts (quality and bioequivalence review)
- Since MAR 2016 : 2 experts (quality and bioequivalence review
assessment) for 6 times per year
JULY 2018 & JULY 2019 Korea-Japan Joint Symposium
JULY 2018 & JULY 2019 Korea-Japan Annual High-level Meeting
NOV 2016 PMDA Quality Experts-Invited Industrial
Meeting
FEB 2017 Published the Comparative Analysis of
Korea-Japan Pharmacopoeias
Promulgation of the Presidential Decree on inclusion of Korea on the
list of “Countries of High Surveillance” in Peru (20 APR 2015)
Korea MFDS-Peru Ministry of Health MOU for mutual cooperation in
pharmaceutical area (9 DEC 2016)
Promulgation of the Presidential Decree on adopting KP as an official
reference in Peru (7 JUN 2017)
Joining proficiency test
Gaining Observership
Short-term visiting scientist program
Regularly attending the European Pharmacopoeia Commission
Meeting
• Signed (APR 2012) and renewed (APR 2015, JUNE 2018) MOU
• Area of cooperation : Strengthen training and capacities
including scientific exchange program, monograph co-
MOU
development, joint symposium
• Annually held Joint Symposium since 2012
- elemental impurities, container packaging, excipient
Symposium management strategies
• Annually held the meeting after 2013
• Area of discussion : monograph co-development, operating
Bilateral MFDS-USP Hot-Line for risk management of pharmaceutical
Meeting products, etc.
Monograph co-development Collaborative testing labs for USP
- Esomeprazole strontium Reference standards
- Gemifloxacin, 6 herbal medicines - ISO 17025 on test methods(`19.12.)
Joint Symposium and Bilateral
Scientific exchange
Meeting
- 8 scientists in total since 2013
- Once a year since 2012
Collaboration with regulatory authorities
Strengthen mutual trust
Thank you
www.mfds.go.kr
Pharmaceutical Standardization Division
Tel . 82-2-43-719-2951 ~ 67
Fax. 82-2-43-719-2950
