Bioequivalence and Bioavailability Forum

The current EMA guidance on bioequivalence requires that the bioanalytical part of bioequivalence trials should be performed in accordance with the principle of GLP. I have recently seen a bioanalytical report for a BE study where only GCP compliance was stated. The justification was that according to the new EMA guidances "Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples" and to the EMA "Guidance on bioanalytical method validation" now only GCP compliance in needed and no declaration on GLP principle compliance is needed any more.

Do you agree on this interpretation?

Thank you

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Edit: Documents linked. [Helmut]