BE wo local originator [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-03-13 10:51 (582 d 11:46 ago) – Posting: # 21266
Views: 1,554

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
[image]

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

Complete thread:

Activity
 Admin contact
21,729 posts in 4,543 threads, 1,543 registered users;
online 10 (0 registered, 10 guests [including 4 identified bots]).
Forum time: Saturday 23:37 CEST (Europe/Vienna)

If you want to converse with me,
define your terms.    Voltaire

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