PANDRH Technical Report Nº 8 - Framework for Implementation of Equivalence Requirements for Pharmaceutical Products

This document has been prepared by the Working Group on BE (WG/BE) of the Pan American Network on Drug Regulatory Harmonization (PANDRH) with the objectives of contributing to Drug Regulatory Authorities (DRAs) of the Region of the Americas and recommending harmonized criteria concerning the equivalence of drugs. The document consists of two parts:

• The first part refers to scientific criteria for implementing therapeutic equivalence.
• The second part of the document refers to the strategic framework for the implementation of studies of drug equivalence.