Pharma_88
☆    

China,
2020-03-13 08:37

Posting: # 21261
Views: 2,204
 

 Bioequivalence Study without approved/marketed or no RLD [Regulatives / Guidelines]

Hello All,

Greetings!!

We got an inquiry to conduct BE for XYZ molecule but at the time of feasibility we came to know that RLD for XYZ molecule is not approved/marketed in our country. Means there is no RLD.

Still sponsor wants to market their product. In this case, what we can do? Can we do directly PK study or Phase III study of sponsor's product in patients?

Thanks.
ping4santosh
☆    

India,
2020-03-13 10:01

@ Pharma_88
Posting: # 21263
Views: 750
 

 Bioequivalence Study without approved/marketed or no RLD

Hello,

If the RLD is unavailable in your country (yet to get register), how would the generic market itself? In EU and middle East, the RLD has to be registered in the target market for the generic to get a chance based on BE. It could be different in China.

What I understand from your draft is that you are the CRO. If sponsor gives you the RLD and test article you can go for pK based study.

Cheers, SKM
Helmut
★★★
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Homepage
Vienna, Austria,
2020-03-13 10:51

@ Pharma_88
Posting: # 21266
Views: 751
 

 BE wo local originator

Hi Pharma_88,

are you really located in China – or rather in Gujarat? :-D

» We got an inquiry to conduct BE for XYZ molecule but at the time of feasibility we came to know that RLD for XYZ molecule is not approved/marketed in our country. Means there is no RLD.

[image]We don’t have a crystal ball. Which country are you aiming at?

» Still sponsor wants to market their product. In this case, what we can do? Can we do directly PK study or Phase III study of sponsor's product in patients?

A foreign reference product is acceptable only in the Eurasian Economic Union and China (and under certain conditions in Australia and South Africa).
AFAIK, a “well established” local product (which is not the originator’s) is possible only in the EEU and China.
Otherwise, Phase III.

Cheers,
Helmut Schütz
[image]

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