Harmonization of Pharmacopoeial Monographs and Test Methods

Abstract

Pharmacopoeial standards for medicinal products and auxiliary substances are widely used for regulatory purposes in public health protection and commerce. This paper provides an overview of attempts to harmonize the divergent standards that exist worldwide by the pharmacopoeial authorities of the United States, Europe, and Japan through the Pharmacopoeial Discussion Group. Where unity cannot be achieved, harmony is the goal. The harmonization process, procedure, and progress to date are described. Plans for the future are outlined.