Chinese & Japanese Pharmacopoeia for Manufacturers

FPMAJ

International Committee

Takashi Morota

諸田 隆

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Summary of FPMAJ(The Federation of Pharmaceutical Manufacturers’ Association of Japan )

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◆Establishment Oct. 16th, 1948

◆Purpose

The Federation investigates and studies necessary mattersfor the development of the pharmaceutical industry, andcollects, complies, and implements impartial suggestionsprovided by the industry. Additionally, the Federationstrives to maintain the relationships, communications anddevelopment among our members, interest and topromote the collective best interest of our affiliatedmembers. Moreover, the Federation acts as thecoordinator to assist in the healthy development of thepharmaceutical industry and strives to improve theoverall quality of life of all citizens.

◆ Members

31 pharmaceutical organization1) Industrial organizations : 15 (Prescriptions, OTC, etc.)2) Regional organizations : 16 (Tokyo, Osaka & other

Prefs.)

Organization of FPMAJ

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日本製药团体连合会

理事长常务理事事务局

会长

评议员会

理事会

副会长

监事

医薬品PL中心

审查部会

总务委员会

企业伦理委员会

医药品PL中心运营协议会

製剂委员会

保险药价研究委员会

Washington条约关系连络会

流通问题连络会

中小企业对策恳谈会

制度调查会

救济制度委员会

個人情報委員会

个人情报委员会

药局方委员会

再评价委员会

环境委员会

国际委员会

个人情报保护中心

PL审查会

安全性委员会

Japanese Pharmacopoeia (JP)& Pharmaceutical Manufacturers

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◆ June, 1886 JP 1st Edition ４６８ articles

・・・◆ Mar., 1951 JP 6th Edition ６３４ articles

Experts from national institutions, academia and manufacturers first joined to editorial members of JP.

・・・

◆ June, 2019 JP 17th 2nd suppl. 2008 articles

日本药典草案讨论委员会的组织结构图

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标準品委员会

生物制品委员会

总合委员会製剂委员会

理化学试验法委员会

药用辅料委员会

国际协调研究委员会

物性试验法委员会

生物试验法委员会

药品名称委员会

生药等(A)委员会

化学药品委员会(1), (2)

抗生物质委员会

生药等(B)委员会

总合

小委员会

制法问题讨论小委员会

製剂WG※

注射用水WG※

Inhalation WG※

完全性评价WG※

色谱WG※qNMR WG※

点鼻剂WG※

※根据研究课题，临时设置工作组(WG)(April, 2019）

Cooperation of Industries on JP

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生药等(A)委员会生药等(B)委员会

Deliberations on whole contents & present articles

Deliberations on new articles

Organaizations of Pharamaceutical industries of Crude Drugs & Herbal producs

日本汉方生药製剂协会日本生药连合会东京生药协会

Industry-government-

academiaPartnership

G

A I

-overnment (Regulation)

(Science) (CMC)＊ *Chemistry, Manufacturing & Control

Example of deliberation onthe crude drugs & Kampo in JP

Committee on Crude Drugs (B) Committee on Crude Drugs (A)

-cademia -ndustry

R & D in Medical fieldpromotive grantssupportive grants

汉方处方WG

色谱研究班

不纯物研究班

q-NMR 研究班

Variation of marker compounds contained in all 424 lots of Syakuyakukanzoto(芍药甘草汤) manufactured in 2017 at Kampo industry A

-50

-40

-30

-20

-10

0

10

20

30

40

50

Glycyrrhitic acid Paeoniflorin

mean ± SD%

×

424 lots1 lot : approx. 2,000 kg

%

Glycyrrhitic acid PaeoniflorinSD(±%） 4.23 2.36<±10% 418 lots 424 lots>±10% 6 lots ―

Our expectation on Pharmacopoeia

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◆Convenient E-Searching System

Chinese Pharmacopoeia (English ver.) web searching system

Web searching system of latest edition of ChP ChP booklet version attached with CD media

Information searching system relevant to pharmaceutical regulation in both countries, for foreign industries Establishment of portal web site indicating total & intensive

information relevant to latest pharmaceutical regulation Establishment of information exchange system between industries in

both countries regarding important revision of pharmaceutical regulations

Aggregation of drug related information Since pharmaceutical regulatory system differ among countries, all

relevant information is expected to be aggregated in the single web site as possible to provide convenience to foreign industries

Exchange & Cooperation examples between China & Japan

pharmaceutical manufacturers

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Cooperation in Traditional Medicines

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1st：2016 Tianjin, China 3rd：2018 Tianjin, China 2nd：2017 Kyoto, Japan 4th：2019 Kawasaki Japan

１）日中药局方（生药等）检讨会

第2回：日中药局方（生药等）检讨会 京都 supported by manufacturers

Exchange program by manufacturers

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CPhI Japan 2019中方：中国医药保健品进出口商会日方：日本製药工业协会、日本製药团体连合会、关西医药品协

会、日本汉方生药製剂协会、日本药业贸易协会

2）日中产业交流会

Cooperation in Traditional Medicines

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３）中日中药产业交流会

广州交易会 2018中方：中国医药保健品进出口商会日方：日本汉方生药製剂协会

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◆ISO/TC249 ： Traditional Chinese Medicine

ScopeStandardization in the field of medical systems derived fromancient Chinese medicine which shall be able to share onecommon set of standards. Both traditional and modern aspectsof these systems are covered. The committee focuses on qualityand safety of raw materials, manufactured products andmedical devices and of informatics, including service standardslimited to involving the safe use and delivery of devices &medicine, but not into the clinical practice or application ofthose products.

Cooperation in Traditional Medicines

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◆ISO/TC249 ： Traditional Chinese Medicine

42under

development

45published ISO

standards

23Participating

members

17Observing members

Secretariat：SAC （ Standardization Administration of the People's Republic of China）

Cooperation in Traditional Medicines

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◆ISO/TC249 ： Traditional Chinese Medicine

WG2 Group Photo at10th ISO/TC249 Plenary Meeting

at Bangkok

Every year!!Friendship party by ISO experts from

China & Japan

Cooperation in Traditional Medicines

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5.2 Moisture The moisture content in percentage mass should not be more than 14,0%.5.3 Total ashThe total ash content in percentage mass should not be more than 6,5%.5.4 Acid-insoluble ash The total ash content in percentage mass should not be more than 1,0%.5.5Water-soluble extractivesThe water-soluble extracts content in percentage mass should not be less than 22,0%.

Traditional Chinese Medicine －#### #### root

Requirements – shall, shall not

Recommendations – should, should not

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Chinese Pharmacopoeia2015 Edition

Hong Kong Chinese Materia MedicaStandards

≤14,0 ≤4,0 ≤1,0 ≥ 16,0

Taiwan Herbal Pharmacopoeia 2nd

edition≤13,0 ≤7,0 ≤1,0 —

Japanese Pharmacopoeia 17th ≤14,0 ≤6,5 ≤0,5 —

Korean Pharmacopoeia

11th

British Pharmacopoeia2015 Edition

European Pharmacopoeia 9.0 ≤12,0 ≤4,0 ≤0,5 —

≤12,0 ≤6,5 ≤0,5 —

≤14,0 ≤6,5 — —

≤14,0 ≤4,0 — ≥ 22,0

Authority Regulation Moisture(%) Total ash (%)Acid-insoluble

ash (%)Water-soluble

extractives (%)

Annex (Informative)Normative（Requirement)

Thank you very much for your attention!

http://www.fpmaj.gr.jp/

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