THE NEED FOR COMPREHENSIVENESS AND INCREASED ENFORCEABILITY IN THE STANDARDIZATION OF INTERNATIONAL PHARMACEUTICAL REGULATIONS

Abstract

This article will discuss the main mechanisms by which the United States and other countries are attempting to standardize their pharmaceutical regulations. I first explore the need for standardization and the potential benefits that standardization offers. Then I sketch the early efforts of nations to move toward standardization. I present and critique the mechanisms by which standardization is currently proceeding and the progress that has been made to date. I also detail the Food and Drug Administration’s (FDA) participation in international standardization. I argue that reform of the standardization process is necessary to reap the full benefits of standardization. Specifically, the various tools of standardization, the ICH, MRAs, and MOUs need to be integrated so as not to work at cross-purposes. The standardization process must be expanded to account for the views of consumers and non-member nations. Most importantly, in the absence of a way to bind nations to commitments to standardize pharmaceutical regulations, standardization mechanism are in danger of becoming another layer of regulatory delay; to avoid this pitfall, standardization agreements must be made enforceable.