Bioequivalence and Bioavailability Forum • Generic application

bkrao
☆

India,
2015-10-16 10:15
(3908 d 20:26 ago)

Posting: # 15567
Views: 4,394

Generic application [Regulatives / Guidelines]

Hi...

With one Bio equivalence study dossier, is there any possibilities to submit the same dossier to other regulatory (if the innovator is same in the other regulatory) for marketing application?

For illustration I have conducted the study intended for USFDA ANDA submission, and submitted the same, and got approvals even, for marketing, then I want to market the same product in the Europe or Canada or any other regulatory, is it possible to submit the same to other regulatory? or I need to conduct the separate BE study? Kindly clarify, if possible.

Thanks & Regards,
B.K.RAO.

Ohlbe
★★★

France,
2015-10-16 13:47
(3908 d 16:54 ago)

@ bkrao
Posting: # 15568
Views: 3,351

Generic application: submission to multiple authorities

Post reply

Dear B.K. Rao,

There are some possible limitations:

the reference product used may not be recognised by the second authority (for instance if you did your study with a US reference product, it won't be accepted in the EU);
the various regulatory authorities may follow different guidelines. For instance scaling is not done the same way in the US and in the EU.

If there is no limitation regarding the reference product or study conduct, the trial can be submitted to several authorities.

—
Regards
Ohlbe