*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.

FDA Public MeetingThe Future of the International Conference on Harmonization of TechnicalRequirements for Registration of Pharmaceuticals for Human Use (ICH)

Overview of ICH: A description of the structure and harmonization process.

Christelle Anquez*Office of International Programs,

Office of Commissioner

I C HINTERNATIONALCONFERENCE ONHARMONISATION

of Technical Requirements for the Registration of

Pharmaceuticals for Human Use

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

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

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.

Three Regions, Six Parties

EuropeEU EFPIA

JapanMHLW JPMA

The United States of AmericaFDA PhRMA

ICH Organisation

• The ICH Steering committee

– ICH Coordinators– The ICH Secretariat (IFPMA)

• Expert Working Groups

Administrative

Technical

Steering CommitteeMeeting Attendees

• TWO MEMBERS FROM EACH OF THE SIX ICH PARTIES

• IFPMA (Secretariat)

• OBSERVERS from Canada, EFTA and WHO

Oversees and monitorsthe Harmonisation Process.

Expert Working Groups

SAFETY EFFICACY

QUALITY REGULATORY COMMUNICATIONS

An EWG for each ICH TopicSix Topic Leaders - one from each ICH party

Role: developing consensus on technical issues

I C HINTERNATIONALCONFERENCE ONHARMONISATION

GUIDELINES

http://www.fda.gov/cder/guidance/index.htm

The Five Steps in the ICH Process for Harmonization of Technical Issues

STEP 5 : Implementation inthe three ICH regions

(Federal Register NoticePost 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

INTERNATIONAL CONFERENCEON HARMONIZATION

• First Conference: Brussels 1991

• Second Conference: Orlando 1993

• Third Conference: Yokohama 1995

• Fourth Conference: Brussels 1997

• Fifth Conference: San Diego 2000

• Sixth Conference: Osaka 2003