On 15 November 2013, the EMA released the first draft product-specific guidance documents on the demonstration of bioequivalence for 16 active substances for public consultation.

This first set of guidance builds upon the general principles set out in the Agency’s Guideline on the investigation of bioequivalence of 2010, which specified the requirements for the design, conduct and evaluation of bioequivalence studies for immediate release dosage forms with systemic action.  These first guidance documents will be followed by another wave of product-specific guidance in the course of 2014.
Continue Reading EMA Releases Its First Product-Specific Guidance on the Demonstration of Bioequivalence for Public Consultation