Japanese Pharmacopoeia(JP)

Japanese Pharmacopoeia(JP) - Present and Future - Seiko Miyazaki, ... JP 16 2011. 3. 31 1764 Suppl. I 2012. 9. ... Sep 2012. Apr 2013;...

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Japanese Pharmacopoeia(JP) - Present and Future -

Seiko Miyazaki, Ph.D. Office Director Office of Standards and Guidelines Development Pharmaceuticals and Medical Devices Agency (PMDA) 1 1st Malaysia-Japan Symposium, 10 March,2015 Pharmaceuticals and Medical Devices Agency (PMDA)

Introduction of Office organization Office of Standards and Guidelines Development Division of Pharmacopoeia and Standards for Drugs ・Secretariat of Japanese Pharmacopoeia Expert committees ・Projects Across Multi-Offices in PMDA (ex. Review Guidelines) ・Registration of Master Files for Drug Substances

Division of Standards for Medical Devices ・ Secretariat of Committees for Certification and Approval Standards ・ Cooperation to Review Guidelines Development

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Pharmaceuticals and Medical Devices Agency (PMDA)

Today’s Topic 1. What’s JP ? 2. How to establish JP ? 3. What’s International Harmonization? 4. JP’s perspective for the future

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Pharmaceuticals and Medical Devices Agency (PMDA)

Today’s Topic 1. What’s JP ? 2. How to establish JP ? 3. What’s International Harmonization? 4. JP’s perspective for the future

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Pharmaceuticals and Medical Devices Agency (PMDA)

History and Legal Status of JP 





JP was first published on June 25, 1886 and implemented on July 1, 1887 → JP has the history of 129 years JP is published by the Japanese Government as a Ministerial Notification by the Ministry of Health, Labour and Welfare JP is published in accordance with the Pharmaceutical & Medical Devices (PMD) Act which is the most fundamental law for pharmaceutical regulation in Japan.

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Pharmaceuticals and Medical Devices Agency (PMDA)

Roles and Characteristics of JP – To show standards for quality of drugs Official – To be used extensively by the persons concerned Public – To be transparent/disclosed information in the process of establishment Transparent

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Pharmaceuticals and Medical Devices Agency (PMDA)

History of JP Edition -Number of Monographs on DrugsDate of publication Number of monographs 1886. 6. 25 468 ↓ ↓ 2011. 3. 31 1764 2012. 9. 27 1837 Partial rev. 2013. 5. 31 1837 2014. 2. 28 1896 Suppl. II ↓ ↓ ↓ about 1970 JP 17 2016 Spring Edition JP 1 ↓ JP 16 Suppl. I

In recent years, the new editions are published every 5 years and two supplements are published between the regular publication of JP editions. Moreover, partial revisions are made as necessary. 7

Pharmaceuticals and Medical Devices Agency (PMDA)

Composition of the JP16 JP16th Edition comprises the following items, Notification of MHLW Contents Preface General Notices General Rules for Crude Drugs General Rules for Preparations General Tests Mandatory Part Official Monographs Ultraviolet-visible Reference Spectra Infrared Reference Spectra General Information Table of Atomic Mass as an appendix 8 Pharmaceuticals and Medical Devices Agency (PMDA) Cumulative Index

Number of texts included in JP16 ( As of February 2014)



Total monograph : 1896 

 



 

monographs for APIs(Including Excipients): 1288 monographs for finished dosage forms: 608 monographs for biologicals APIs: 32 finished dosage forms: 43 monographs for Herbal products: 291

General tests: 73 supplementary texts(Information Chapters): 43

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Pharmaceuticals and Medical Devices Agency (PMDA)

JP English version - JP16 and its Supplements -

JP

Japanese

English

JP16

Mar 2011

Feb 2012

JP16 Suppl. I

Sep 2012

Apr 2013

JP16 Suppl. II

Feb 2014

Sep 2014

• JP English electric version can be downloaded freely from the JP English website; http://www.pmda.go.jp/english/pharmacopoeia/index.html 10

Pharmaceuticals and Medical Devices Agency (PMDA)

Reference Standards for JP ( as of April 2014 )

Classified as application Chemical drugs

206

Biologics

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(1)

(2)

Distributor

Number

251 Crude drugs

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General test

9

Antibiotics

125

Total amount

376

PMRJ

NIID

(1) PMRJ : Pharmaceutical and Medical Device Regulatory Science Society of Japan 11 (2) NIID : National Institute of Infectious Diseases, Japan Pharmaceuticals and Medical Devices Agency (PMDA)

Today’s Topic 1. What’s JP ? 2. How to establish JP ? 3. What’s International Harmonization? 4. JP’s perspective for the future

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Pharmaceuticals and Medical Devices Agency (PMDA)

Schedule of JP Publication JP 16th Edition (JP16)

Published in March 2011

• Basic

Principles for Preparation of JP17

(Published in September 2011)

• Guideline for Drafting JP17

Supplement I to JP16 Published in September 2012

(Published in December 2011) (Partially revised in May 2014)

Good Pharmacopoeial Practices in JP

Supplement II to JP16 Published in February 2014

JP 17th Edition (JP17)

To be published in 2016 spring 13

Pharmaceuticals and Medical Devices Agency (PMDA)

Basic Principles for Preparation of JP17 Published in September 2011

1. Include all drugs which are important for health care and medical treatment 2. Make qualitative improvement by introducing the latest science and technology 3. Promote internationalization 4. Make prompt partial revision as necessary and facilitate smooth administrative operation 5. Ensure transparency regarding the revision, and disseminate the JP to the public 14

Pharmaceuticals and Medical Devices Agency (PMDA)

Secure System for Establishing JP MHLW, JP Committee/ PAFSC* - Basic Principles - Determination of Drugs to be listed in JP PMDA

*PAFSC: Pharmaceutical Affairs Food Sanitation Council Request

Industry Draft Draft Submission

Secretariat’s Draft

Questions Expert Committees- Review

Pharmaceutical Industry

Answers &

JP Draft for Public Comment

Public Consultation

JP Final Draft

MHLW, JP Committee/ PAFSC* - Adoption and Promulgation of JP - Publication of JP (English Translation)

Other Stakeholders

Public Consultation 15

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Organization of JP Expert Committees

Update; June 1, 2014

Com. on Chemicals (1) and (2) Sub-Com. on Manufacturing Process-related Matters

Com. on Antibiotics Com. on Biologicals Com. on Crude Drugs(B) - Com. on Crude Drugs (A) Com. on Excipients - WG (Alchoholimetric Table)

Standing Committee

Com. on Nomenclature for pharmaceuticals Com. on Reference Standards

For Monographs

Com. on Drug Formulation - 3 WGs (Dissolution, Inhalation, Com. on Physical Methods Sub-Standing Com.

Adhesive Capacity)

Com. on Biological Methods - WG (Aseptic Process) Com. on Physico-Chemical Methods - WG (Rubber Closure) For General tests

Com. on International Harmonization – WG(Prospective Harmonization) 16

Pharmaceuticals and Medical Devices Agency (PMDA)

Today’s Topic 1. What’s JP ? 2. How to establish JP ? 3. What’s International Harmonization? 4. JP’s perspective for the future

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Pharmaceuticals and Medical Devices Agency (PMDA)

Pharmacopoeial Discussion Group(PDG) 

European Pharmacopoeia (EP),United States pharmacopeia (USP) and Japanese Pharmacopoeia (JP) participate.



It was launched in 1989. WHO started participating as an observer in 2001.



It meets twice per year. The latest meeting was held in Strasbourg on 12-13 November, 2014.



Harmonization is carried out retrospectively for existing excipient monographs and general chapters or prospectively for new monographs or chapters.

General Chapters Monographs

Harmonized Items (under revision)

In progress

29 (4)

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48 (10)

14

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Pharmaceuticals and Medical Devices Agency (PMDA)

Pharmacopoeial Harmonization - Objective & Scope Reduction of stakeholders’ burden of dealing with analytical procedures in different ways, using different acceptance criteria  Updating level of science and Contribution to the assurance of the public health  Harmonization of General Chapters and Excipient Monographs 19

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PDG process improvement: 







Simplify the PDG process and speed-up the elaboration of harmonized texts Ensure transparency of the PDG activities for each stakeholder Expand the scope of PDG harmonization items

New scheme for interchangeability: 

Objective of ICH Q4B was to declare if the texts published



in the three pharmacopoeias are interchangeable. Because of the cessation of activity of ICH Q4B, it is needed to discuss with regulatory authorities how to evaluate and declare “Interchangeability”. 20

Pharmaceuticals and Medical Devices Agency (PMDA)

Today’s Topic 1. What’s JP ? 2. How to establish JP ? 3. What’s International Harmonization? 4. JP’s perspective for the future

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Pharmaceuticals and Medical Devices Agency (PMDA)

Strategy for the future  JP is considered to play an important role as Pharmaceutical standards based on PMD Act.  In the progress of globalization, JP is expected to have a role with flexibility, to prevent low quality products from being imported into Japan.  To contribute to enhancement of public health, JP is to be exploited eagerly, developing as internationally user friendly pharmacopoeia.

Pharmaceuticals and Medical Devices Agency (PMDA)

Roadmap for the PMDA International Vision Five Important Areas Where RMs are needed 1) Response to advanced science and technology 2) Improvement of international operation basis 3) Dissemination of English information on regulatory review of medicinal products, especially publication of review reports in English 4) Dissemination of information and international cooperation on safety measures

5) Increase of the leverage of Japanese Pharmacopoeia (JP) ・Publish the newest JP version simultaneously in English and Japanese. ・Enhance cooperative relationship with the USP, EP, WHO and each Asian pharmacopeia. Website: http://www.pmda.go.jp/english/international/pdf/PMDA_International_Vision/20130527_roadmap.pdf 23

Pharmaceuticals and Medical Devices Agency (PMDA)

JP; Road map for the PMDA International Vision Background Japan needs to strengthen its international interactions in order to enhance the international status of the JP. Objectives and goals • JP is used in many countries and regions as the international standard, and has been updated properly • JP actively puts more effort into the discussion of the PDG and efficiently promotes the international harmonization of test methods, excipients, and official monographs. 24 Pharmaceuticals and Medical Devices Agency (PMDA)

Priorities to be addressed 

For internationalization of pharmacopoeia   





Prompt publication of the JP English Edition Further improvement on the JP English Website Promotion of the PDG activities and practical use of PDG harmonized texts worldwide Buildup of the frameworks for international information exchange among pharmacopoeias e.g. Cooperation with the International Meeting of World Pharmacopoeias (WHO) Enhance cooperative relationships with other pharmacopoeias e.g. Workshop for training, Exchange of experts 25

Pharmaceuticals and Medical Devices Agency (PMDA)

Expectations for NPCB PMDA(JP) would like to express sincere respect for your efforts in promotion of Public Health in Malaysia. PMDA(JP) would like to promote cooperation with NPCB by sharing experience in international harmonization of pharmaceutical regulations through ICH and PDG, etc. PMDA(JP) hopes that NPCB will utilize the Japanese Pharmacopoeia to ensure the Quality of Pharmaceuticals as one of Reference Pharmacopoeias in Malaysia. 26 Pharmaceuticals and Medical Devices Agency (PMDA)

Summary Roles and Characteristics of JP Official and Public Standards to Ensure Quality of Drugs published by the Japanese Government.

System of Establishing JP Based on Five basic principles and secure process Setting Process; PMDA : Scientific Drafting MHLW: Government Implementation

International Harmonization of Pharmacopeia

The collaborative activity of PDG ; JP (MHLW/PMDA), EP (EDQM), USP (USPC) and WHO as observer

JP’s perspective for the future Road map for the PMDA International Vision and JP Strategy. JP would like to strengthen the cooperation with NPCB. 27

Pharmaceuticals and Medical Devices Agency (PMDA)

JP Home-page @ PMDA Website http://www.pmda.go.jp/english/pharmacopoeia/index.html

PMDA Top Page

Japanese Pharmacopoeia Top Page

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Pharmaceuticals and Medical Devices Agency (PMDA)

Thank you for your attention ! Terima kasih !!

Please visit to our website: http://www.pmda.go.jp/english/pharmacopoeia/index.html E-mail: [email protected] 29

Pharmaceuticals and Medical Devices Agency (PMDA)