Bioequivalence and Bioavailability Forum • Generic application: submission to multiple authorities

Generic application: submission to multiple authorities [Regulatives / Guidelines]

posted by Ohlbe – France, 2015-10-16 13:47 (3909 d 17:54 ago) – Posting: # 15568
Views: 3,352

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

Generic application bkrao 2015-10-16 08:15
- Generic application: submission to multiple authoritiesOhlbe 2015-10-16 11:47