The European Medicines Agency has released its first product-specific guidance on the demonstration of bioequivalence for 16 active substances.  The guidance documents are released for a three-month public consultation. Comments should be made using the submission form and sent no later than 15 February 2014 to


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Bioequivalence studies are conducted as part of the development of generic medicines to demonstrate that they are bioequivalent to a reference medicine. Demonstration of bioequivalence can also be required in other situations such as the assessment of marketing-authorisation variations, fixed-dose combinations, extensions of indication and hybrid applications.


This is the first wave of product-specific bioequivalence guidance, and the Agency intends to continue developing this type of guidance, which is based on the general principles set out in the Agency’s overarching Guideline on the investigation of bioequivalence, with another wave planned in 2014.  The aim is to enable a consistent approach to the assessment of applications supported by bioequivalence data, particularly generic applications, across all authorisation routes i.e. centralised, decentralised, mutual-recognition and national authorisation procedures.


The guidance is intended to help companies design study programmes that meet the expectations of European Union regulators, allowing for better transparency and predictability of the scientific assessment during the authorisation process.  For each medicine, the document provides guidance in the form of a table on:

  • biopharmaceutical classification system (BCS);
  • type of bioequivalence study design;
  • analyte (parent drug or metabolite) to be evaluated;
  • bioequivalence assessment.


The 16 actives substances covered by these guidance documents are: capecitabine; carglumic acid; dasatinib; emtricitabine/tenofovir disproxil; erlotinib; imatinib; memantine; miglustat; oseltamivir; posaconazole; repaglinide; sirolimus; sorafenib; tadalafil; telithromycin; voriconazole. More product-specific guidance on the demonstration of bioequivalence will be released in 2014.  


Posted on the EMA website on 15 November 2013