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FDA Public Meeting Preparation for the ICH Meetings in Tokyo, Japan, Including Progress on

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 20857.

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FDA Public Meeting Preparation for the ICH Meetings in Tokyo, Japan, Including Progress on

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  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 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 presenter’s and do not necessarily represent the views of the U.S. Food and Drug Administration.

  2. I C HINTERNATIONALCONFERENCE ONHARMONISATIONof 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 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.

  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 HINTERNATIONALCONFERENCE ONHARMONISATIONGUIDELINEShttp://www.fda.gov/cder/guidance/index.htm

  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 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

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