The Pacific Rim Good Laboratory Practice Initiatives

Abstract

The U.S. Food and Drug Administration (FDA) Good Laboratory Practice (GLP) Regulations have been in effect since December 22, 1978, and subsequently have become a way of life for all who need to conduct preclinical safety and health effects studies for regulatory submission. The Organization of Economic Co-operation and Development (OECD) with its world-wide membership of 26 (including Japan), and the European Community (EC) with its 12 members, utilized the GLPs to finalize their own standards. Japan, with its six GLP standards for assessing data integrity and quality, became an integral force in the Pacific Rim and a dominant figure in promulgating OECD GLP standards and directives. Third world countries are identifying with Japanese principles and administrative applications of these standards. This presentation focuses on an overview of Japan's GLP standards.