mangurohit
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India,
2010-02-02 09:20
(4373 d 18:59 ago)

Posting: # 4692
Views: 3,644
 

 Japan BE requirement [Regulatives / Guidelines]

Dear Friends,

Myself Mr. Mangu Rohit. I need your help to solve the query i have as below.

If we have to market our product in Japan, is it compulsory to do bioequivalence study in Japan only or we can do the bioequivalence study in other country (like India ) also and submit it to Japan regulatory are they accepting the data??

If Japan regulatory is not accepting the Bioequivalence study data performed in other countries then why it is not accepting??

and if accepting the data of bioequivalence study done in (few countries) which are these countries?

Thanks in advance

Regards

mangu
Helmut
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Vienna, Austria,
2010-02-02 15:03
(4373 d 13:15 ago)

@ mangurohit
Posting: # 4694
Views: 3,590
 

 Brazil's CROs

Dear Mangu!

» If we have to market our product in japan, is it compulsory to do bioequivalence study in Japan only or we can do the bioequivalence study in other country (like India ) also and submit it to Japan regulatory are they accepting the data??

According to Japanese Guidelines subjects must be of 'Japanese ethnic origin' (no exceptions). If you want to perform a study ouside of Japan, I would suggest to go to Sao Paulo. You will find there they largest Japanese community (0.5 Mio) outside of Japan. There are a couple of CROs approved by the ANVISA specialized in these kinds of studies.

Dif-tor heh smusma 🖖
Helmut Schütz
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mangurohit
☆    

India,
2010-02-03 05:21
(4372 d 22:57 ago)

@ Helmut
Posting: # 4697
Views: 3,300
 

 Bioequivalence in Japan

Dear Friends,

Hope this mail finds you in pink of your health and spirit.

Further to the response to my query about the approval of generic drug in Japan necessiates Japanese population only, I would like to know than what are the different ethnic factors (or other factors) that differenciate japanese population from others (e.g. Indian Population)?

Kindly provide the reasons (Provided by regulatory body) if you have, why only Japanese population is required for the bioequivalence study, for the approval in Japan market?

According to ICH E5, Is it not applicable to apply foreign clinical data in Japan?

Hope for the quick response.
Mangu Rohit


Edit: Linked to previous thread; see the Policy. [Helmut]
Helmut
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Vienna, Austria,
2010-02-03 11:10
(4372 d 17:08 ago)

@ mangurohit
Posting: # 4698
Views: 3,332
 

 Bioequivalence in Japan

Dear Mangu

» Kindly provide the reasons (Provided by regulatory body) if you have, why only japanese population is required for the bioequivalence study, for the approval in japan market?

Please :google: (quickly)
Japanese are different in their genotypes of some enzymes, achlororhydria is (much!) more common than anywhere in the world, guidelines call for studies in fast metabolizers only (even in cross-over studies), etc....

» According to ICH E5, Is it not applicable to apply foreign clinical data in japan?

Yes it is applicable, but then you will have to perfom an additional bridging study as well!
  • BE study (test vs. reference in Indian subjects)
  • Bridging study (Indian subjects vs. Japanese subjects)
Do you like to do that?

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Brus
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Spain,
2021-02-24 16:30
(333 d 11:48 ago)

@ Helmut
Posting: # 22233
Views: 794
 

 Japanese Guideline of Bioequivalence

Dear Helmut,

» According to Japanese Guidelines subjects must be of 'Japanese ethnic origin' (no exceptions). If you want to perform a study ouside of Japan, I would suggest to go to Sao Paulo. You will find there they largest Japanese community (0.5 Mio) outside of Japan. There are a couple of CROs approved by the ANVISA specialized in these kinds of studies.

I have consulted the Japanese Bioequivalence guideline and I have not seen this mention. Where does this requirement come from? Where does it appear in the guideline or legislation?

Best regards,
Helmut
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Vienna, Austria,
2021-02-24 18:07
(333 d 10:12 ago)

@ Brus
Posting: # 22234
Views: 755
 

 Japanese Guideline of Bioequivalence

Hi Brus,

» I have consulted the Japanese Bioequivalence guideline and I have not seen this mention. Where does this requirement come from? Where does it appear in the guideline or legislation?

You are aware that you are referring to a post which is whopping eleven years old?
The last time I’ve heard about this requirement was at the ‘EUFEPS/BABP Network Open Discussion Forum’ (Barcelona, 23/24 February 2011).
The Japanese guideline is of 2012…

[image] The Times They Are A-Changin’

If in doubt, see there. ;-)

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Brus
☆    

Spain,
2021-02-25 11:46
(332 d 16:32 ago)

@ Helmut
Posting: # 22235
Views: 701
 

 Japanese Guideline of Bioequivalence

Hi Helmut,

Of course times change.

It is only to know if this requirement is still in force, or it is no longer necessary to perform bioequivalence in the Japanese population, or if it has to be performed in the Japanese population, it is not necessary to perform it in Japan. Does anyone know or have recent experience on this topic?

Best regards,
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