Global Harmonization

Efforts beyond ICH

Justina A. Molzon, MS Pharm, JD

Associate Director for International Programs

Center for Drug Evaluation and Research

US Food and Drug Administration

ICH Steering Committee Member

The views expressed in this presentation are those of the author and do not necessarily represent the views of the U.S. Food and Drug Administration 1

Harmonization in Drug Regulation

Process of integrating national standards withProcess of integrating national standards with international standards to be universally acceptableinternational standards to be universally acceptable to participating countries toto participating countries to facilitate efficient globalfacilitate efficient global drug development and local registrationdrug development and local registration

✦Technical and science requirements

✦Format and content of dossiers

✦Assessment and review practices

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3

ICH INTERNATIONAL CONFERENCE ON

HARMONIS/ZATION of

Technical Requirements

for the Registration of

Pharmaceuticals for Human Use

http://www.ich.org Hosted by ICH Secretariat

IFPMA-Geneva, Switzerland 3

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A Unique Approach • ICH was created in 1990 • Agreement between the EU, Japan and the USA

to harmonize different regional requirements forregistration of pharmaceutical drug products – Canada, EFTA and WHO participate in ICH as

observers

• Unique because joint effort by regulators and

associated pharmaceutical industry trade

associations (includes Generics and OTC)

• Pharmaceutical industry aware of areas of disharmony in regulatory submission requirements

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5

ICH Harmonized Guidelines

• Efficacy - 16 topic headings/20 guidelines • Safety - 9 topic headings/15 guidelines • Quality - 10 topic headings/39 guidelines • Multidisciplinary (Regulatory Communications)

– Medical Dictionary - MedDRA – Electronic Standards - ESTRI, E2B, eCTD

• In 1996 ICH industry representatives proposed assembling the information generated by these harmonized guidancesin the same order

• Goal was to decrease the amount of time and staff needed to assemble and disassemble documents for submission to ICH regions 5

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Concerns • Regulators realized the amount of time and

energy needed to rearrange paper from one ICH region submission format to another

• Conversion caused a delay in submitting an application to that ICH region

• Resulted in delayed access to new innovative medicines for patients in that region

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ICH CTDICH CTD

1.0 Regional Administrative I

Module 1

Module 3 Module 4 Module 5

2.1

2.2

2.3 2.4 2.5

2.6 2.7

1.0

Quality 3.0

Nonclinical Study Reports

4.0

Clinical Study Reports

5.0

1.1 ToC of Module 1 or overaincluding Module 1

2.1 ToC of the 2.2 Introduction

Module 2 2.3 Quality Ove2.4 Nonclinical 2.5 Clinical Ove2.6 Nonclinical

2.7 Clinical S

Source: ICH Impleme

nformation

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ll ToC,

CTD (Mod 2,3,4,5)

rall Summary

Overview

rview

Summary

ummary

ntation Coordination Group

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Benefits of the CTD--FDA Perspective

• More reviewable applications More logical order of presentation Follows development scheme

• More predictable format • More consistent reviews • Easier analysis across applications • Easier exchange of information • Facilitates electronic submissions

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eCTD Format and the Review Process

ICH Guidelines

CTD

eReview

Easier to Develop Standardized Reviewer eTemplates

Promotes eSubmission and eReview tools

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ICH Global Influence

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ICH Global Cooperation Group

• Created in 1999 to address increasing interest by non-ICH parties in ICH guidelinesand operations

• Initial focus on information-sharing • Soon became clear that more active

engagement was necessary to respond toincreasing interest in ICH and ICHguidelines

• Invited participation of regional 12pharmaceutical harmonization initiatives

•

•

AP– A

AS– A

GC– PA– P

SA– S

•

•

•

Regional Harmonization Initiatives

EC sia-Pacific Economic Cooperation

EAN ssociation of the Southeast Asian Nations

C Gulf Cooperation Council NDRH an American Network for Drug Regulatory

Harmonization DC

outhern African Development Community 13

Expanded GCG ICH Meetings June 8-12, 2008

• Participation of individual countries for first time

• Distinct and complementary to participation of official RHI representatives

• Expansion of GCG to specific countries based on considerations such as: • Source of APIs, medicinal products and

clinical data for ICH regions • Use or intended use of ICH guidelines

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Expanded GCG

Invitations Extended to Individual Drug

Regulatory Authorities

• Australia • India • Brazil • Korea • China • Russia • Chinese Taipei • Singapore

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Regulators Forum • Met for the first time prior to ICH meetings

in Portland, June 9, 2008 • Created to promote discussion and sharing

of best practices among regulatory authorities on issues related to the implementation of ICH guidelines andimpact on regulatory systems

• The Regulators’ Forum will complement activities and objectives of GCG

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ICH Week Steering Committee

GCG meeting expanded

Industry meeting (ICG)

Regulators meeting

ThursWedTueMonSun

Regulators Forum

ICH Working Groups

Complementary 17

Core GXP Information

GMP, GCP PCV

GRP, CTD

MHLW EMEA

HC

Swiss

FDA

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Develop > DisseminateDisseminate > ImplementImplement

Conclusion • The geographical face of international drug

development and trade is rapidly changing

• Interest and use of ICH guidelines by non-ICH countries reflects this change

• The influence of ICH on drug development and the submission process will most likely spread across both ICH and non-ICH regions

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Thank you for yourThank you for your

attentionattention

Commissioned Corps of the United States Public Health Service Protecting,

promoting, and advancing the health and safety of the Nation

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