BE wo local originator [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-03-13 10:51 2a02:8388:6bc2:ce80:856f:1d4e:74d9:7171 – Posting: # 21266
Views: 751

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]

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

Complete thread:

Activity
 Admin contact
20,460 posts in 4,297 threads, 1,414 registered users;
online 12 (1 registered, 11 guests [including 8 identified bots]).
Forum time (Europe/Vienna): 21:41 CEST

Genius is that which forces
the inertia of humanity to learn.    Henri Bergson

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5