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
10:30 AM to 2:00 PM
5630 Fishers Lane, Room 1066, Rockville, MD
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 presenter’s and do not necessarily represent the views of the U.S. Food and Drug Administration.

2. I C H INTERNATIONAL CONFERENCE ON HARMONISATION of Technical Requirements for the Registration of Pharmaceuticals for Human Use

3. 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

4. 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

5. 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 R&D process, as a consequence.
Quicker access to patients of safe and effective new medicines.

6. Three Regions, Six Parties
Europe
EU EFPIA
Japan
MHW JPMA
The United States of America
FDA PhRMA

7. ICH Organisation Administrative Technical The ICH Steering committee
ICH Coordinators
The ICH Secretariat (IFPMA)
Expert Working Groups

8. Steering Committee Meeting Attendees
TWO MEMBERS FROM EACH OF THE SIX ICH PARTIES
IFPMA (Secretariat)
OBSERVERS from Canada, EFTA and WHO
Oversees and monitors
the Harmonisation Process.

9. 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

10. I C H INTERNATIONAL CONFERENCE ON HARMONISATION GUIDELINES http://www

11. 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

12. 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

13. Approaching The Target ICH 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