Regulatory Submission in Europe in Absence of Reference product [Regulatives / Guidelines]

posted by drgunasakaran1  – 2021-05-20 07:20 (197 d 11:11 ago) – Posting: # 22360
Views: 3,221

Dear Abhay Patil,

» The Individual product are present in Europe for more than 20 years and their equivalent Generics too available and filed under WEU. so in such case is it necessary to do BABE study

Yes. We need to conduct studies even though equivalent Individual Product Generics are available in the EU Market.

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.

Complete thread:

Activity
 Admin contact
21,785 posts in 4,556 threads, 1,547 registered users;
online 7 (0 registered, 7 guests [including 2 identified bots]).
Forum time: Friday 17:32 CET (Europe/Vienna)

A drug is that substance which, when injected into a rat,
will produce a scientific report.    Anonymous

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