Bioequivalence and Bioavailability Forum

Dear all,

via this link you can find EMA's rev. 2 of the ICH E6 guideline for Good Clinical Practice which is now in consultation.

I think the guideline is very useful in general; for innovator trials it makes sense to me. But I note the new section 5.1 which contains potentially radical changes to habits and an introduction of the risk principle and I wonder what all this means to BE. BE trails in my opinion tend to be somewhat tighther regulated in practice although this isn't distinctly written anywhere. So how does section 5.1 translate into proper practice when we talk BE? Is it a radical change or is it a formalisation of what is already a proper practice?

Some examples that popup in my head:
As per 5.1.1-7 we must identify risks for reliability and how much deviation we can tolerate (5.1.4). OK, bioanalysis is an example. Then we have a ton of regulation in place, with requirements for assay validation, QCs introduced in every run with clear pass/fail requirements, plus ISR to verify actual sample reproductibility. We cannot really deviate from such requirements in practice and that's completely OK with me. So what does 5.1.1-5.1.7 really achieve?
Same would go for safety reporting or protection of subjects. Much regulated, and in practice with zero tolerance for deviations (e.g. you get a critical for sharing a piece of paper with sponsor that mentions a phone number of a subject or for forgetting an AE, and rightfully so).

So I am really in doubt here how the new risk-related aspects of ICH E6 in its present form would translate into new practices for BE. I would like to hear your thoughts and thank you all in advance for them.