Bioequivalence and Bioavailability Forum

Dear All,

I have question regarding the selection of reference product for all Europe region. So if I select any reference product which is listed or authorized in UK market then the study conducted for MHRA can be submitted in other region of EU? or we have to select the reference product form each applicable Europe region for submission. we are looking for UK, France, Germany and other region of EU.

Second question is do we have any documentary proof which states that the regulatory criteria (guidance document of EU) of EU and reference product of EU region accepted by the TGA (Australia)for submission or we have to select reference product marketed in Australia only.

With addition to this we have few more market where we would like to work and searching information for Romania,Switzerland, Netherlands, Poland, Malaysia, Philippines, Indonesia,Vietnam

Your valuable suggestion are very well awaited.

Regards,


Compliance