Bioequivalence and Bioavailability Forum

Hi all,

I have a client who is reviewing an 505(b)(2) NDA and keen to use the Biostudy in an EU submission. The EU legal framework seems pretty clear, in that you can only use an RMP, for the BioEq study, approved/marketed in Europe.

Any thoughts on providing enough manufacturing evidence to claim EU and US RMPs are equivalent? or is this an absolute given the RMP must be manufactured and marketed in EU?

Thanks

Peter