Continuing Equivalence: Is There an End to the Story?

Abstract

For many active pharmaceutical ingredients and their corresponding drug products, the possibility of a single global system of harmonised bioequivalence and pharmaceutical equivalence requirements for first-entry and interchangeable multi-source drug products may be considered. The topic should be of interest to all manufacturers, to practitioners and patients as well, and to government policy-makers. In an era when substandard, counterfeit, and adulterated medicines are increasingly available, the topic requires careful consideration.