International Conference on Harmonisation (ICH)

ICH was organised to provide an opportunity for tripartite harmonisation initiatives to be developed with input from both regulatory and industry representatives; ICH is concerned with harmonisation of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan and the United States; the six ICH sponsors are: The European Commission, the European Federation of Pharmaceutical Industries Association, the Japanese Ministry of Health and Welfare, the Japanese Pharmaceutical Manufacturers Association, the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA, and the Pharmaceutical Research and Manufacturers of America; the ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA); the ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organisation, the Canadian Health Protection Branch, and the European Free Trade Area.