EMA: Compilation of individual product-specific guidance on demonstration of bioequivalence

The general European Union requirements for bioequivalence demonstration are laid out in the Guideline on Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1). In addition, the CHMP started in 2009 to publish positions addressing specific questions in relation to the requirements and assessment of bioequivalence studies (EMA/618604/2008). This document describes the regulatory view on product specific aspects related to the demonstration of bioequivalence, based on previous assessments of generic medicines. This should facilitate transparent, predictable and scientifically robust evaluation of future generic marketing authorisation procedures.