Rasha_J ☆ Jordan, 2016-05-15 12:39 (2874 d 04:32 ago) Posting: # 16304 Views: 9,107 |
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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 ★★ Russia, 2016-05-18 09:09 (2871 d 08:02 ago) @ Rasha_J Posting: # 16320 Views: 7,791 |
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Hi Rasha_J, 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:
Good luck (you'll need it)! — Kind regards, Mittyri |
Beholder ★ Russia, 2016-05-19 17:25 (2869 d 23:46 ago) (edited by Beholder on 2016-05-20 10:20) @ Rasha_J Posting: # 16333 Views: 7,727 |
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❝ 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 Rasha_J! 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 |
Rasha_J ☆ Jordan, 2017-06-06 13:27 (2487 d 03:43 ago) @ Beholder Posting: # 17448 Views: 6,413 |
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Dear All Many thank for all responses highly appreciated |
Marika ☆ Czech Republic, 2017-06-06 21:20 (2486 d 19:50 ago) @ Rasha_J Posting: # 17454 Views: 6,521 |
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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 ★★★ Vienna, Austria, 2017-06-07 01:55 (2486 d 15:15 ago) @ Marika Posting: # 17456 Views: 6,450 |
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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 to retrieve the list of accredited institutions. Growing fast.
Edit:
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Beholder ★ Russia, 2017-06-07 18:23 (2485 d 22:47 ago) @ Marika Posting: # 17458 Views: 6,424 |
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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 ★ Russia, 2017-06-23 12:13 (2470 d 04:57 ago) @ Marika Posting: # 17498 Views: 6,167 |
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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? — Best regards Beholder |