BE wo local originator [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-03-13 10:51 (225 d 02:38 ago) – Posting: # 21266
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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.

Dif-tor heh smusma 🖖
Helmut Schütz
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