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Back to the forum  Query: 2017-08-17 01:27 CEST (UTC+2h)
 
Quality-RJ
Junior

Jordan,
2016-05-15 10:39

Posting: # 16304
Views: 3,125
 

 Russian BE requirement [Regulatives / Guidelines]

Dear All;

Can you please advise if you have to be an approved CRO by Russian MOH before you run and submit a study to Russia, like the system in Brazil, the Turkish MOH and the Gulf countries.

Thanks in Advance
mittyri
Senior

Russia,
2016-05-18 07:09

@ Quality-RJ
Posting: # 16320
Views: 2,277
 

 Russian BE requirement

Hi Quality-RJ,

If you need to register your MP as BEQ product in Russia, you need more than just to be an approved CRO.
I would suggest the following plan:
  1. to discuss with your Russian registration department or company which can do the registration steps in Russia the Plan of Drug investigation
  2. to contact with Russian CRO
Please note that it is impossible to register the MP in Russia without conducting the study in Russia. Most of BEQ sites are affiliated with the CROs and only russian CROs know all tricks and traps of study submission to MOH (yeah, a lot of!). If you don't have an experience of study submission in Russia, don't waste your money and efforts and delegate it.
Good luck (you'll need it)!

Kind regards,
Mittyri
Beholder
Junior

Russia,
2016-05-19 15:25
(edited by Beholder on 2016-05-20 10:20)

@ Quality-RJ
Posting: # 16333
Views: 2,196
 

 Russian BE requirement

» Can you please advise if you have to be an approved CRO by Russian MOH before you run and submit a study to Russia...

Hello Quality-RJ!

I have never heard about such approval from Ministry of Health for CRO. I know that there is such approval (accreditation) for medical sites (clinics). There is a list of all clinics approved and one can see this list on special site. Also there is special procedure and application for that. So if such procedure was for the CRO then it would need a special list of CRO. But I never saw such a list before.

Best regards
Beholder
Quality-RJ
Junior

Jordan,
2017-06-06 11:27

@ Beholder
Posting: # 17448
Views: 1,008
 

 Russian BE requirement

Dear All
Many thank for all responses
highly appreciated
Marika
Junior

Czech Republic,
2017-06-06 19:20

@ Quality-RJ
Posting: # 17454
Views: 985
 

 Russian BE requirement

Dear All,

nothing like formal accreditation of CROs by Russian Ministry of Health exists. Nevertheless, Russian Ministry of Health carries out CGP and GLP inspections (they are organized by Roszdravnadzor, which is connected with MoH).

Nevertheless for registration of generics, Russia accepts only BE studies conducted in Russia (I mean their clinical part). It is explicitly written in Russian legislation.

Russia has own accreditation system for clinical sites and for investigators (it is not specific for BE or Phase 1, it is a general accreditation to act in clinical studies). The system for accreditation of Clinical Sites was launched approx 2012-13.
Helmut
Hero
Homepage
Vienna, Austria,
2017-06-06 23:55

@ Marika
Posting: # 17456
Views: 977
 

 List of accredited clinical sites

Dear Marika,

» The system for accreditation of Clinical Sites was launched approx 2012-13.

An amazing site. For those of you not knowing Russian: Click найти to retrieve the list of accredited institutions. Growing fast.

31 Oct 2016: 1,222
29 Apr 2017: 1,275
31 May 2017: 1,284
06 Jun 2017: 1,287


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Helmut Schütz 
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The quality of responses received is directly proportional to the quality of the question asked. ☼
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Beholder
Junior

Russia,
2017-06-07 16:23

@ Marika
Posting: # 17458
Views: 934
 

 Russian BE requirement

Dear Marika,

» Nevertheless for registration of generics, Russia accepts only BE studies conducted in Russia (I mean their clinical part). It is explicitly written in Russian legislation.

However, if we take Russia as part of EAEU then clinical trials performed before 1.01.2016 on territories of countries of ICH region will be considered during registration.

<36. При регистрации лекарственного препарата отчеты о проведенных клинических исследованиях, включенные в состав модуля 5 его регистрационного досье, рассматриваются в процессе экспертизы при соблюдении одного из следующих условий:
...
клинические исследования проведены частично или полностью на территориях стран региона Международной конференции по гармонизации технических требований к регистрации лекарственных препаратов для медицинского применения (ICH) до 1 января 2016 г. (по дате последнего визита последнего пациента), на основании которых лекарственный препарат зарегистрирован на территориях стран региона Международной конференции по гармонизации технических требований к регистрации лекарственных препаратов для медицинского применения (ICH);
...>

Best regards
Beholder
Beholder
Junior

Russia,
2017-06-23 10:13
(edited by Beholder on 2017-06-23 10:27)

@ Marika
Posting: # 17498
Views: 679
 

 Russian BE requirement

Hello, colleagues!

» nothing like formal accreditation of CROs by Russian Ministry of Health exists.

Surprisingly, I found an interesting thing. Look at the screenshot below. It is a part of the application form for obtaining the permission for clinical trial from the-best-of-the-best site. This part is called "another organizations, taking part in clinical trial". So, I inputed name of one of the biggest CRO in the world, which has representative office in Russia. As result you can see that there is "Code of organization" field (marked with red) and nimber (!) of organization. So, looks like there is hidden list of CRO because I could not input the CRO which has no number (Tryed to input "ромашка" (chamomile) - nothing changed, no number assaigned). Do somebody know smth about this number?
[image]

Best regards
Beholder
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