International Conference harmonisation initiatives

It would be wrong to give the impression that the PAT initiative is confined to the FDA. The FDA has increased its collaboration with international health and regulatory partners, including the International Conference on Harmonisation for the Technical Requirements for Registration of Pharmaceuticals (ICH) and the International Cooperation on Harmonisation of Technical Requirements for Veterinary Medicinal Products (VICH). 

The International Conference on Harmonisation differs from many other harmonization initiatives in that it has a recognized status and is backed by a commitment on the part of both industry and regulators, to facilitate greater harmonization of technical requirements in the three regions. Commitment to these objectives, set out in the Terms of Reference, was re-affirmed by the Steering Committee in a statement issued following the meeting held in Tokyo, October 1990. 

International Conference on Harmonisation (ICH) The ICH was formed to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. The ICH is sponsored by the European Commission, the European Federation of Pharmaceutical Industry Associations, the Japanese Ministry of Health and Welfare, the Japanese Pharmaceutical Manufacturers Association, the U.S. Food and Drug Administration, and the Pharmaceutical Research and Manufacturers of America. The objective of the ICH is to harmonize the technical requirements for the registration of pharmaceutical products in the European Union, Japan, and the United States. 

International Conferences on Harmonisation. URL http // www.ich.org. The ICH Web site provides information on the structure and purpose of this consensus-building initiative, as well as the process for evolving recommendations regarding technical requirements for human drug registration worldwide. Separate sections address existing Guidelines, the Common Technical Document, and MedDRA. 

Since then the importance of meta-analysis has grown. Not only has there been an explosion in published analyses over the past twenty years, but initiatives such as that of the Cochrane collaboration of databases as well as the trend towards evidence-based medicine make it both easier to use meta-analysis on the one hand and less acceptable not to do so on the other. In drug development, while being satisfied with an expert s judgement alone in the past, the regulator now expects to see it backed up with a formal overview of all studies. (See, for example, ICH E9 (International Conference on Harmonisation, 1999).) Like them or hate them, meta-analyses are here to stay. 

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