The European Medicines Agency (EMA) publishes product-specific guidance for the demonstration of bioequivalence on its website under the heading "Product-specific bioequivalence guidance". The relevant principles for study design can be found there in a standardised format.
The final versions for individual products will be published once they have been adopted by the Committee for Medicinal Products for Human Use after at least three months of public consultation. If the EMA receives comments during the consultation phase, these will be made available for download together with the final guidance documents.
New finalised guidelines of the following substances were published at the end of June 2023: