International Conference on Harmonization-Good Clinical Practices Update

Abstract

This paper presents an introduction to the “International Conference on Harmonization Good Clinical Practices Consolidated Guideline” for professionals who are already familiar with Food and Drug Administration (FDA) clinical trial standards. A brief background on the International Conference on Harmonization (ICH) is provided. ICH-GCP is then compared to FDA standards. ICH guidelines are well supported by industry and FDA. As a result of ICH, regulatory requirements are becoming clearer and more harmonized, the quality of clinical studies is improving, and the acceptance of foreign data is increasing within the ICH regions. Harmonization of the format and content of marketing applications, which is anticipated to be completed in the next few years, will bring more benefits.