The views expressed in this presentation are those of the presenters and do not necessarily represen

1
FDA Public Meeting Preparation for the ICH
Meetings in Tokyo, Japan, Including Progress on
the Common Technical Document and Possibilities
for New Topics May 8, 2001 1030 AM to 200
PM 5630 Fishers Lane, Room 1066, Rockville, MD
20857
Overview of ICH A description of the structure
and harmonization process.
CHRISTY UNDERDONK Office of International
Programs Food and Drug Administration
The views expressed in this presentation are
those of the presenters and do not necessarily
represent the views of the U.S. Food and Drug
Administration.
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I C HINTERNATIONALCONFERENCE ONHARMONISATIONof
Technical Requirements for the Registration of
Pharmaceuticals for Human Use
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A Unique Approach

• Agreement between the European Union, Japan and
  the USA to take action on Harmonisation
• A joint initiative involving regulators and
  industry as equal partners in technical
  discussions

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Inauguration of ICH

• April 1990, EFPIA Offices, Brussels First meeting
  of the Six Parties, and IFPMA
• To plan an International Conference
• To establish Terms of Reference
• To establish a Method of Working

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ICH Objectives

• Identification and elimination of the need to
  duplicate studies to meet different regulatory
  requirements.
• More efficient use of resources (human, animal,
  material) in the RD process, as a consequence.
• Quicker access to patients of safe and effective
  new medicines.

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Three Regions, Six Parties
Europe EU EFPIA Japan MHW JPMA The United
States of America FDA PhRMA
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ICH Organisation
Administrative Technical

• The ICH Steering committee
• ICH Coordinators
• The ICH Secretariat (IFPMA)
• Expert Working Groups

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Steering CommitteeMeeting Attendees

• TWO MEMBERS FROM EACH OF THE SIX ICH PARTIES
• IFPMA (Secretariat)
• OBSERVERS from Canada, EFTA and WHO

Oversees and monitors the Harmonisation Process.
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Expert Working Groups
SAFETY EFFICACY QUALITY
REGULATORY COMMUNICATIONS
An EWG for each ICH Topic Six Topic Leaders - one
from each ICH party Role developing consensus
on technical issues
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I C HINTERNATIONALCONFERENCE ONHARMONISATIONGU
IDELINEShttp//www.fda.gov/cder/guidance/index.h
tm
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The Five Steps in the ICH Process for
Harmonization of Technical Issues
STEP 5
Implementation in
the three ICH regions
(Federal Register Notice
Post on CDER Website)
STEP 4
Agreement on a harmonized
ICH guideline adopted by regulators
STEP 3
Regulatory consultation in the three
regions. Consolidation of the comments
(Federal Register Notice / Post on CDER Website)

STEP 2
Agreement by the Steering Committee to release
the
draft consensus text for wider consultation
STEP 1
Building scientific consensus in joint
regulatory/industry expert working
groups
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INTERNATIONAL CONFERENCE ON HARMONIZATION

• First Conference Brussels 1991
• Second Conference Orlando 1993
• Third Conference Yokohama 1995
• Fourth Conference Brussels 1997
• Fifth Conference San Diego 2000

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Approaching The TargetICH 4, 16-18 July 1997
Brussels
Special Requirements for US Registration
Special Requirements for Registration in Japan
Conflicts Resolved
No Conflicts Identified
Special Requirements for EURegistration
ICH Guidelines