The Drive toward Regulatory Harmonization: What is Harmonization and How Will it Impact the Global Development of New Drugs?

Abstract

A great deal of discussion is heard about regulatory harmonization and efforts to shorten the drug submission regulatory review process. This article provides a historical perspective of the International Conference on Harmonization (ICH), its organizational structure, objectives, the five-step process, status of ICH guidelines, and recent progress. It also examines other "harmanization '' initiatives such as the Declaration of Helsinki, World Health Organization (WHO), Council for International Organizations of Medical Sciences I (CIOMS I), CIOMS II, International Standards Organization (ISO) 9000, and European Union (EU) directives and regulations related to medicinal products. As a consequence of the growing body of regulations that have expanded the drug development process, it is appropriate to reevaluate drug development information needs and consider necessary changes in the management of the process to improve the quality of submissions and to reduce the global time to market.