Download presentation
Published byVivien Payne Modified over 9 years ago
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
Similar presentations
© 2024 SlidePlayer.com. Inc.
All rights reserved.