TRS 1052 - Annex 6: WHO Biowaiver List: proposal to waive in vivobioequivalence requirements for WHO Model Listof Essential Medicines immediate-release, solid oraldosage forms

Overview

The WHO solubility classification, also referred to as the WHO Biowaiver List, is a tool for national regulatory authorities and pharmaceutical manufacturing companies, suggesting medical products that are eligible for a waiver from in vivo bioequivalence studies, which are usually necessary to establish the therapeutic equivalence with the originator (comparator). For exemption from an in vivo bioequivalence study, an immediate-release, multisource (generic) product should exhibit very rapid or rapid in vitro dissolution characteristics that are comparable to those of the reference product. A risk-based evaluation should also account for the excipients used in the formulation of the finished pharmaceutical product.