Ⅰ

Ⅱ

Ⅲ

Ⅰ

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

-

-

632

1,182

1,013

1,212

1,308

1,428

1,482

1,485

1,511

1,559

2,462

-

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

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

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

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.

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

Ⅱ

`15

• Korean Pharmacopoeia Discussion Group in operation constantly (Pharmaceutical Standardization Division)

`16

• 3-year plan for international harmonization of KP (Pharmaceutical Policy Division)

`17

• Revising the manual of KP revision (Pharmaceutical Standardization Division)

`18

• 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)

`19

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

• 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

General Notices

General Requirements for PharmaceuticalPreparations

Monographs Part 1

Monographs Part 2

General Tests,Processes andApparatus

GeneralInformation

• Communicate with the public on the revision process of KP 12 on the MFDS website

• Exclusive email for KP 12 as ‘Kopharm’ (kopharm@korea.kr)

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)

Ⅲ

Support for domestic pharmaceutical products

Stronger network with other regulatory authorities

Support for trade of pharmaceutical products in cooperation with industry

• 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)

• Implemented in Korea

Q3D

• Joined EWG

• Q3C(R8) Step 1

Q3C

• Joined EWG

• Step 3

Q12

• Joined EWG

• Step 1

Q13

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

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.

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

Collaboration with regulatory authorities

Strengthen mutual trust

Thank you

www.mfds.go.krPharmaceutical Standardization Division

Tel . 82-2-43-719-2951 ~ 67Fax. 82-2-43-719-2950