06c Global Pharmacopoeial Initiatives 2014-03-07

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Prescription/Non-Prescription Stakeholder Forum

Meeting #5 for 2010-2015

Friday, March 7, 2014

Global Pharmacopoeial Initiatives

Angela G. Long, M.S.Senior Vice President, Global Alliances and Organizational Affairs


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Pharmacopoeias Overview Current Harmonization Efforts


Topics


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Pharmacopoeias in the World (According to WHO/2012)29 of the 49 are part of the European Pharmacopoeia

3

ArgentinaCzech

RepublicHungary Japan Pakistan Slovakia Ukraine

Austria Denmark Iceland Kazakhstan Philippines SloveniaUnited

Kingdom

Belarus Egypt India Korea Poland Spain UnitedStates

Belgium Finland Indonesia Lithuania Portugal Sweden Viet Nam

Brazil France Iran Mexico Romania Switzerland Chile

China Germany Ireland MontenegroRussian

FederationThailand Europe

Croatia Greece Italy Norway Serbia Turkey WHO


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RxNorm: 11,000 approved drug products and their ingredients in

the US

Global Market of Medicines


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Pharmacopoeia Total

British Pharmacopoeia 3,300

Chinese Pharmacopoeia 4,569

European Pharmacopoeia 2,224*

Indian Pharmacopoeia 2,500**

Japanese Pharmacopoeia 1,764

United States Pharmacopeia 4,700

Pharmacopoeial Monographs

* Drug substance monographs only

** 2014 Edition


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Topics


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World Health Organization

Expert Committee on Specifications of PharmaceuticalPreparations

Expert Committee on Biological Standards

International Nonproprietary Names

International Congress on Harmonization (Medicines)

APEC Life Sciences Forum

ISO Remco (Reference Standards)

Pharmacopoeial Harmonization

Pharmacopoeial Discussion Group

Prospective Harmonization (I, II, III)

Bilateral Agreements (MOUs)

Regional Harmonization Efforts

Pharmacopoeial Meetings

Harmonization Efforts


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USP resolves to strengthen and expand its efforts to

work with pharmacopeias, industry, academia,

regulators, international organizations and other

stakeholders around the world to develop harmonized

global standards.

USP Convention Resolution 5


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A global industry wants harmonized standards

Regulators need standards

Pharmacopoeias are downstream from regulatoryauthorities

Harmonization is hard, especially retrospective

Other approaches are emerging, e.g., convergence

Pharmacopoeial Harmonization


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USPs Bilateral Agreements (MOUs)


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Adopt/Adapt Agreements

Translations Visiting Scientist Program/International Training Program

Science and Standards Symposia

Study Tours

Education Programs Capacity Building Support (e.g., Technical Assistance)

USP Standards-setting Activities Chemical Medicines

Biological Medicines

Excipients Herbal Medicines/Dietary Supplements

Foods

Reference Standards

Harmonization through Bilateral Agreements


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European Pharmacopoeia 36 Member States

29 pharmacopoeias harmonized (drug substance monographs and

general chapters)

Mercosur Pharmacopoiea

Activities have begun

ASEAN Pharmacopoeia

Discussions just beginning

Regional Pharmacopoeias


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Topics


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ICDRA

Singapore 2002 , Madrid 2004, October 2012

WHO International Meeting of World Pharmacopoeias

Geneva February-March 2012 (#1),

India April 2013 (#2)

London April 2014 (#3)

Chinese Pharmacopoeia and USP (Global Summit of the

Pharmacopoeias)

Beijing November 2011 (#1)

Xian September 2012 (#2)

Baltimore September 2013 (#3)

Pharmacopoeial Meetings


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Introduction

Purpose and Scope of Good Pharmacopoeial Practices Monograph Development

General Considerations Technical Guidance

Monographs for starting materials, including active pharmaceutical

ingredients and excipients Monographs for finished pharmaceutical products

Monographs for compounded pharmaceutical preparations

Monographs for biologicals

Monographs for herbals

Monographs for other products

Reference Substances

Analytical Test Procedures and Methodologies

Principles of Collaboration and Exchanges Among Pharmacopoeias

Collaboration with Stakeholders

WHO Good Pharmacopoeial Practices


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Sponsored by the Chinese Pharmacopoeia and USP and

includes all pharmacopoeias Pharmacopoeias signed a statement that envisions a

day when all medicines moving in national and international

commerce will have optimal public standards.working in a

science-based, transparent and collaborative way, seekinginput from all interested parties.

Three meetings; the first two in China, the third in Baltimore

Focus areas:

Optimal Drug Substance and Product Monographs Global Pharmacopoeial Database/Index (ChP)

Spectral Libraries (USP)

Global Summit of the Pharmacopoeias


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Combining the WHO and GSP Meetings


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A Dream

In addition to excipients, globally harmonize drug

substance and drug product monographs

Consider innovative monograph development

approaches

Strengthen pharmacopoeial interactionconsider

sharing the workload across pharmacopeias to create

needed public standards

Leverage other resourceswork collaboratively withregulatory authorities/universities/industry on standards

development

Utilize global experts


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06c Global Pharmacopoeial Initiatives 2014-03-07

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