(2002; 166 pages)
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.