Bioequivalence and Bioavailability Forum 00:51 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Beholder
Regular

Russia,
2018-02-28 08:00

Posting: # 18476
Views: 594
 

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

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
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
18,697 posts in 3,982 threads, 1,238 registered users;
online 13 (0 registered, 13 guests [including 9 identified bots]).

Science should always be the basis
of regulatory requirements.    Joachim Röhmel

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed