Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Close this folderHarmonization I
View the documentThe harmonization process of ICH
View the documentEuropean contribution to a global approach to regulation
View the documentThe harmonization process of ICH - philosophy, process and future
View the documentImpact of ICH on non-ICH countries
View the documentICH - its value to a first-line medicines regulator
View the documentRecommendations
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

The harmonization process of ICH

Dr Yoshikazu Hayashi, Japan

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals (ICH) was established in 1990 as a joint initiative of the United States of America, the European Union and Japan, based on an idea raised at an ICDRA meeting. These three regions account for more than 90% of all new drug development in the world. The main purpose of ICH is to eliminate duplication of work and procedures caused by different regulatory requirements, to cut down on waste of resources, and to give timely access to safe, effective and good quality new drugs.

ICH is a scientific forum rather than a forum for global politics or trade negotiations. ICH is the conference on innovative drug products. ICH guidelines, which specify “how to collect data scientifically for marketing authorization”, are not mandatory, and their application thus depends on the commitment of the ICH parties.

The guidelines are produced through expert working groups (EWG) and steering committees (SC). First, experts are selected for an EWG, which prepares a rough draft guideline. The draft is considered by a steering committee before being released to the public for comments. The regulatory authorities consolidate the comments and return them to the EWG, which modifies the draft guideline accordingly. The final draft is adopted by the SC and implemented through the regulatory systems in the three regions. If a guideline is not self-explanatory, seminars or workshops may be conducted.

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