Overview of the Fourth International Conference on Harmonization

Abstract

This overview of the Fourth International Conference on Harmonization (ICH 4), held in Brussels, Belgium, 16-18 July 1997, summarizes results and provides information regarding the nonclinical workshop and issued nonclinical testing guidelines [Draft Final (Step 4) Guidelines recommended for adoption to the regulatory bodies of the EU, Japan, and the USA]. ICH 4 completed the initial harmonization targets for the three ICH Regions [European Commission-European Union (EU) and European Federation of Pharmaceutical Industries' Association (EFPIA); Ministry of Health and Welfare (MHW) Japan and Japan Pharmaceutical Manufacturers Association (JPMA); and the U.S. Food and Drug Administration (FDA) and Pharmaceutical Research and Manufacturers of America (PhRMA)] and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). Proceedings will be available in book form. Earlier conferences, guidelines, and proceedings are available on CD-ROM and in print and diskette form from the ICH Secretariat, c/o IFPMA, 3 rue de St.-Jean, P.O. Box 9, 1211 Geneva 18, Switzerland; Tel +41 (22) 340 12 00; Fax +41 (22) 345 82 75. Similar information is obtainable from the ICH Home Page (http://www.ifpma.org/ich1.html) and the Pharm Web home page (http://www.pharmweb.net).