RLD identification in EU region in view of Brexit [Regulatives / Guidelines]

posted by shahajan baig  – India, 2021-08-31 16:49 (822 d 11:30 ago) – Posting: # 22556
Views: 2,357

Dear Member,

Hope everyone is safe and healthy in this pandemic situation.

I wanted to know about RLD identification & selection in EU region since we do not have any specific source like in USFDA which provides the orange book data or OGD guidance. Also, we don't have several product-specific guidance in EU regions. Ao in such conditions how can we identify & select RLD in EU region? Also please guide me about how Brexit impacted DCP and CP in EU union for the selection of RLD.

A response will be highly appreciated

Regards,

SHAHAJAN BAIG

Complete thread:

UA Flag
Activity
 Admin contact
22,811 posts in 4,783 threads, 1,638 registered users;
29 visitors (0 registered, 29 guests [including 9 identified bots]).
Forum time: 03:19 CET (Europe/Vienna)

Inspiration is constantly in the air.
It’s up to us to develop the sensitivity
to pick up on it.    Herbie Hancock

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