TRS 1052 - Annex 8: Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability

Overview

These guidelines provide recommendations to regulatory authorities when defining requirements for approval of multisource (generic) pharmaceutical products in their respective countries. The guidance provides appropriate in vivo and in vitro requirements to assure interchangeability of the multisource product without compromising the safety, quality and efficacy of the pharmaceutical product.