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RegisterEuropean BE study for Canada? [Regulatives / Guidelines]
Dear all
We conducted an open label BE study with our test product against the European innovator product. Would it be possible to submit this study to get a marketing authorization in Canada?
I see two problems:
a) The study was not blinded (see 2.4.2 of the Canadian BE guideline), but I think there are good arguments against this demand
b) The reference product was the European innovator product but this is also marketed in Canada.
Has anyone experience with this situation? I am unable to find C.08.004 in the Food and Drug Regulations (C.R.C., c. 870) http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.%2C_c._870/page-288.html#h-297
I am looking forward to your advice.
Kind regards
Dan
We conducted an open label BE study with our test product against the European innovator product. Would it be possible to submit this study to get a marketing authorization in Canada?
I see two problems:
a) The study was not blinded (see 2.4.2 of the Canadian BE guideline), but I think there are good arguments against this demand
b) The reference product was the European innovator product but this is also marketed in Canada.
Has anyone experience with this situation? I am unable to find C.08.004 in the Food and Drug Regulations (C.R.C., c. 870) http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.%2C_c._870/page-288.html#h-297
I am looking forward to your advice.
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- European BE study for Canada?Dr_Dan 2012-05-29 09:56
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- European BE study for Canada? jag009 2012-05-30 18:13
- European BE study for Canada? Vijaya 2012-06-01 10:44
- European BE study for Canada? Dr_Dan 2012-06-01 12:19
Ing. Helmut Schütz