PowerPoint 프레젠테이션 · Herbal Drugs 179 Biological Drugs 49 Radioactive Drugs 28 Combined...
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KP Edition Revision Date English Version Monographs
First Edition
Second Edition
Third Edition
Fourth Edition
Fifth Edition
Sixth Edition
Seventh Edition
Eighth Edition
Ninth Edition
Tenth Edition
Eleventh Edition
Twelfth Edition
10 OCT 1958
10 OCT 1967
10 DEC 1976
01 MAY 1982
22 APRIL 1987
07 APRIL 1992
31 DEC 1997
30 DED 2002
28 DEC 2007
27 DEC 2012
05 DEC 2014
Scheduled in 2019
1998
2003
28 DEC 2008
18 NOV 2013
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-
632
1,182
1,013
1,212
1,308
1,428
1,482
1,485
1,511
1,559
2,462
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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
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Prepare a draft revision of Korean Pharmacopoeia
Review new or revised items
Adopt revised Korean Pharmacopoeia
Deliberation on revised Korean Pharmacopoeia by Central pharmaceutical affairs review committee
Produce final draft of revised Korean Pharmacopoeia
Formulate concrete plans for revision of Korean Pharmacopoeia
Solicit comments from Industry and Academia
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Performing laboratory study to develop test methods
Planning and Management
Cross checkExternal advisory Experts
NIFDS
Advising lab-test related issued
NIFDS regional brancheslab institutes
NIFDS labsAcademic labsPharmaceutical companies
Work-flow
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General Notices
General Requirements for Preparations
Monographs
Part I : Frequently used drugs and primary preparationsPart II : Crude drugs, biological drugs, combined preparations, additives for preparations and quasi-drug
General Tests, Processes and Apparatus
General Information
Index
11th Edition was promulgated on 5 DEC 2014.
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Monographs – Part I 2,009Monographs – Part II 453
Herbal Drugs 179Biological Drugs 49Radioactive Drugs 28Combined Preparations 19Additives 162Quasi Drugs 16
Total 2,462
Part I : Frequently used drugs and primary preparationsPart II : Crude drugs, biological drugs, combined preparations,
additives for preparations and quasi-drug.
KP 11th Edition
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`15
• Korean Pharmacopoeia Discussion Group in operation constantly (Pharmaceutical Standardization Division)
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• 3-year plan for international harmonization of KP (Pharmaceutical Policy Division)
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• Revising the manual of KP revision (Pharmaceutical Standardization Division)
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• Roadmap for entire revision of KP (draft) (Drug Research Division, 2016-2018)
`19.5• Finalized KP 12TH edition (draft) (May 2019)
`19.9• Notification of the entire revision of KP (September 2019)
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Strengthen safety management based on new technologies and improve user experience
Quality Innovation
Big DataUser-friendly
Platform for high level of
quality assurance
To respond to the 4th industrial revolution,
strengthen safety control and enhance
regulatory flexibility
Supporting drug development with
new technologies and enhancing
convenience/utilization
Test methods for new tech, more info on control
of manufacturing and quality
Providing KP in digital format based on DB
Electronic system will be user-friendly and provide more information
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• Introduction of QbD and control of impurities and containers/packaging
General Notices
• Inclusion of new criteria for performance evaluation for each dosage form
General Requirements for Pharmaceutical
Preparations
• Modernization of Specification and more rigorous control of impurities
Monographs
• Reinforcement of safety management and inclusion of new test methods
General Tests, Processes and
Apparatus
• Provision of more information on manufacturing and quality control
General Information
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General Notices
General Requirements for PharmaceuticalPreparations
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Monographs Part 1
Monographs Part 2
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General Tests,Processes andApparatus
GeneralInformation
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• Communicate with the public on the revision process of KP 12 on the MFDS website
• Exclusive email for KP 12 as ‘Kopharm’ ([email protected])
All year round public consultation
• Major purpose and changes for KP 12 and public consultation on site
• Future direction for KP and cases of foreign pharmacopoeias
International Symposium for Revision of KP 12 (June 2019)
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Ⅲ
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Support for domestic pharmaceutical products
Stronger network with other regulatory authorities
Support for trade of pharmaceutical products in cooperation with industry
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• 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)
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• Implemented in Korea
Q3D
• Joined EWG
• Q3C(R8) Step 1
Q3C
• Joined EWG
• Step 3
Q12
• Joined EWG
• Step 1
Q13
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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
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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
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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
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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)
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Joining proficiency test
Gaining Observership
Short-term visiting scientist program
Regularly attending the European Pharmacopoeia Commission Meeting
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MOU
• Signed (APR 2012) and renewed (APR 2015, JUNE 2018) MOU
• Area of cooperation : Strengthen training and capacities including scientific exchange program, monograph co-development, joint symposium
Symposium
• Annually held Joint Symposium since 2012- elemental impurities, container packaging, excipientmanagement strategies
Bilateral Meeting
• Annually held the meeting after 2013
• Area of discussion : monograph co-development, operating MFDS-USP Hot-Line for risk management of pharmaceutical products, etc.
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Monograph co-development
- Esomeprazole strontium
- Gemifloxacin, 6 herbal medicines
Collaborative testing labs for USP Reference standards
- ISO 17025 on test methods(`19.12.)
Joint Symposium and Bilateral Meeting
- Once a year since 2012
Scientific exchange
- 8 scientists in total since 2013
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Collaboration with regulatory authorities
Strengthen mutual trust
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Thank you
www.mfds.go.krPharmaceutical Standardization Division
Tel . 82-2-43-719-2951 ~ 67Fax. 82-2-43-719-2950