Bioequivalence and Bioavailability Forum

Good evening to everyone.
I have a question related to the study population to be enrolled for a Bioequivalence study. Up till now, I was confident on the fact that, at least in the EU (I know the FDA thinks differently), the EMA guideline did not request the study population to be mixed (male and female). But at the moment, we are planning a biostudy in Jordan, and given our usual practice of enrolling only male subjects, the CRO recommended not to mention this in the study title (“healthy volunteers”, instead of “healthy male volunteers”), arguing that they have received the following question from an EU authority (Italy): “The selection of exclusively male subjects in the bioequivalence study should be adequately justified”
My question is: do you know if there has been any regulatory change on that field which could explain such a question?
Thanks.

Regards,

Marcel