International Council for Harmonization Stability Guidelines: Food and Drug Administration Regulatory Perspective

Abstract

The International Conference on Harmonization (ICH) was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: the European Community, Japan, and the United States. The six ICH sponsors are the European Commission, the European Federation of Pharmaceutical Industry Associations, the Japanese Ministry of Health and Welfare, the Japanese Pharmaceutical Manufacturers Association, the Food and Drug Administration (FDA), and the United States Pharmaceutical Manufacturers Association. In addition, the ICH secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Association (IFPMA).