Bioequivalence and Bioavailability Forum

Dear All,

Greetings!

We are developing a topical ointment (5-Fluorouracil) for US and EU.

US reference product is manufactured by Valeant in Canada.
EU reference product is manufactured by Meda in Poland.

As of now we plan to conduct three arm study (Test product, US reference product, Placebo) to file in US. Is there any chance that MHRA (EU regulatory authority) will accept this study?? or we should include EU reference product as well i.e. four arm study (Test product, US reference product, EU reference product, Placebo)?

Secondly, if four arm study is conducted then MHRA and FDA would accept the statistical significance of clinical data?

Lastly, whether study should include subjects from different parts of India / US /EU or only Indian population would suffice??

Your views will be really helpful for further Proceedings.

Thank you.


Regards,
Samaya.

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Edit: Category changed. [Helmut]