FDA harmonization task force report

Executive Summary

Has been completed and will be available within two weeks from the National Technical Information Services (NTIS). In Dec. 9 "Talk Paper," FDA said the report "makes recommendations for future agency activities and calls for continuing discussions" in the GATT and NAFTA talks, with the European community and "in other forums," to "encourage international cooperation." FDA says the report also "addresses the need for adequate resources to carry out international programs and cites increased costs, such as those required for conducting foreign inspections, as a driving force" for efforts to harmonize manufacturing standards and enforcement. FDA points out that it has Memoranda of Understanding on GMP inspections with Canada, Sweden and Switzerland and the agency "is exploring the possibility of agreements with Japan, Australia, the EC and others".