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RegisterSubmission in USA & Canada [Regulatives / Guidelines]
Hi,
No. My previous company was specialized in ANDAs and 505b2 (controlled release). You cannot submit USA ANDA studies for Canadian submission or vice versa due to the reference product being different.
Even 505b2 we had to run BA (or BE) studies to compare against the reference from each country if we want to submit.
If you run a BE /BA study with three treatments (Test, US Reference, CAN reference) then I think you can do it. I did this kind of study before for a NDA / NDS submission in USA and CAN (actually 2 NDS submissions)
Hope this helps.
John
❝ Is it possible to submit the same study conducted for USA in CANADA also? I have asked question for the reference product to be used for CANADA but unfortunately no one has replied me.
No. My previous company was specialized in ANDAs and 505b2 (controlled release). You cannot submit USA ANDA studies for Canadian submission or vice versa due to the reference product being different.
Even 505b2 we had to run BA (or BE) studies to compare against the reference from each country if we want to submit.
If you run a BE /BA study with three treatments (Test, US Reference, CAN reference) then I think you can do it. I did this kind of study before for a NDA / NDS submission in USA and CAN (actually 2 NDS submissions)
Hope this helps.
John
Complete thread:
- Submission in USA & Canada Compliance 2013-07-05 13:29
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Canadian reference Helmut 2013-07-05 14:15
- Canadian reference Compliance 2013-07-06 06:32
- Non-Canadian reference Helmut 2013-07-06 15:20
- Non-Canadian reference jag009 2013-07-06 23:29
- Non-Canadian reference Helmut 2013-07-07 13:49
- Non-Canadian reference jag009 2013-07-06 23:29
- Non-Canadian reference Helmut 2013-07-06 15:20
- Canadian reference jag009 2013-07-07 01:26
- North American POVs / posting statistics Helmut 2013-07-07 14:49
- Canadian reference Compliance 2013-07-06 06:32
- Submission in USA & Canadajag009 2013-07-06 23:22
- Submission in USA & Canada luvblooms 2013-07-08 06:06
- Submission in USA & Canada Compliance 2013-07-08 09:01
- Submission in USA & Canada jag009 2013-07-08 15:12
- Submission in USA & Canada luvblooms 2013-07-08 06:06
- Canadian reference Helmut 2013-07-05 14:15
Ing. Helmut Schütz