Agreement between Russia and Belarus for clinical trials (BE) [Regulatives / Guidelines]

posted by Beholder  – Russia, 2018-02-28 08:00 (1333 d 21:16 ago) – Posting: # 18476
Views: 1,183

Hello!

There is an Agreement between the Government of the Russian Federation and the Government of the Republic of Belarus of 14.12.2007 "On the development of cooperation in the field of production and mutual supplies of medicines" where we can find following info (sorry, only cyrillic text is available by the link):

"Article 6

Each Party shall recognize the results of preclinical and clinical studies of medicinal products, including bioequivalence studies conducted in the State of the other Party, provided that they are conducted in accordance with the requirements established by the authorized bodies of the Parties.
The Parties reserve the right, if necessary, to design additional trials of medicinal products."

My question is: does anybody have positive/negative experience during registration procedure in Russia using clinical trial (including BE) results from Belarus and vice versa?

Does it work at all?

THX in advance.

Best regards
Beholder

Complete thread:

Activity
 Admin contact
21,753 posts in 4,548 threads, 1,544 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time: Sunday 06:16 CEST (Europe/Vienna)

They were “so intent of making everything numerical”
that they frequently missed seeing
what was there to be seen.    Barbara McClintock

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