Bioequivalence and Bioavailability Forum

Hi all,

Please check out this document from the EU commission.
Q: If a phase of a field trial is conducted in another Member State under the supervision of a principal investigator and a GLP compliance claim is made, should the principal investigator's test site be a member of the national compliance monitoring programme of that Member State?
A: The study director (or the principal investigator at the local test site) should inform the compliance monitoring authority in the country where the site is located before the start of the study phase. The compliance monitoring authority of the country where the site is located will then take a decision on a case by case basis.

This makes good sense. But since our guideline on BE requires GLP compliance (and consequentially a statement of that), I might be inclined to conclude that EU CROs must now inform GLP authorities everytime bioanalyses in a BE trial has been conducted. Note that even if our BE guideline was updated (say, with its own Q&A stating that no such contact is required for the sake of dossier approval) it would still not legally release a BE CRO from its duty to comply with the commissions Q&A.
This could get interesting. Perhaps there is a way to argue that BE trials are not field trials?

Let me hear your thoughts, please.