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Anand ☆ India, 2015-03-27 06:28 (3461 d 20:32 ago) Posting: # 14619 Views: 8,585 |
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Dear All, Request to clarify BE Study in Russia,whether BE Study has to be conduct in Russsia? We have filed the Dossier to WHO & US same can be filed in Russia? BABE Forum Russia that link not working. Hence Please provide BE Guideline & Requirement in Russia Link Thanks in Advance for your help Regards, Anand Biopharmaceutics & Pharmacokinetics(Bio-PK) |
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Beholder ★ Russia, 2015-03-27 10:46 (3461 d 16:14 ago) @ Anand Posting: # 14621 Views: 6,891 |
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Hello Anand, According to actual RU GL you has to conduct the local BE study exactly in Russia. — Best regards Beholder |
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Anand ☆ India, 2015-03-27 11:24 (3461 d 15:36 ago) @ Beholder Posting: # 14623 Views: 6,900 |
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Dear beholder, Thanks for your reply. Request to provide,
Anand Bio-PK Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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Beholder ★ Russia, 2015-03-27 13:21 (3461 d 13:39 ago) @ Anand Posting: # 14624 Views: 6,891 |
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❝ I. link Russian BE Guideline & Drug data base search(russia) Actually this GL 2008 from BEBAC library is the old one. I have new GL 2013 but only in Russian. ❝ II. If the product already available in russia with two marketed players, then BE Study required & has to be performed in Russia. Yes, you are absolutely right. — Best regards Beholder |
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Helmut ★★★   Vienna, Austria, 2015-03-27 15:16 (3461 d 11:44 ago) @ Beholder Posting: # 14625 Views: 6,994 |
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Hi Beholder, ❝ I have new GL 2013 but only in Russian. Are you referring to Chapter 7* of the “Red Book”? @Anand: Contact me by e-mail. I can send you an unofficial (‼) English translation. Use at your own risk.
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Beholder ★ Russia, 2015-03-29 18:36 (3459 d 09:24 ago) @ Helmut Posting: # 14628 Views: 6,727 |
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Hello Helmut, ❝ Are you referring to Chapter 7* of the “Red Book”? Yes, exactly. But pages are like this: 174-215. BTW. There will be a new GL for EEU coming into force most probably after January 1, 2016. — Best regards Beholder |
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Alyssa ☆ Malaysia, 2020-10-05 08:00 (1442 d 19:59 ago) @ Beholder Posting: # 21970 Views: 3,264 |
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Hello Beholder, ❝ There will be a new GL for EEU coming into force most probably after January 1, 2016. May I have the new guideline for Russian BE? I could only find the 2008 version in the guideline section. Or anyone can share with me if you have a copy in English. Thank you. |
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Beholder ★ Russia, 2020-10-05 13:34 (1442 d 14:26 ago) @ Alyssa Posting: # 21971 Views: 3,243 |
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Hello Alyssa, ❝ May I have the new guideline for Russian BE? Yes, sure. Just go to the Guidelines page of this site and find EEU section. Russia is part of the EEU. Unfortunately only Russian text is available. — Best regards Beholder |
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Brus ★ Spain, 2020-10-01 18:05 (1446 d 09:55 ago) @ Beholder Posting: # 21956 Views: 3,711 |
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Dear Beholder and all, Should the entire clinical trial be done in Russia or only the clinical part? I mean, can the bioanalytical part be done outside of Russia? Best regards, |
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Helmut ★★★ Vienna, Austria, 2020-10-01 18:47 (1446 d 09:13 ago) @ Brus Posting: # 21958 Views: 3,690 |
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Hi Brus, ❝ Should the entire clinical trial be done in Russia or only the clinical part? I mean, can the bioanalytical part be done outside of Russia? AFAIK, it can. — 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 |
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Brus ★ Spain, 2020-10-01 18:51 (1446 d 09:09 ago) @ Helmut Posting: # 21959 Views: 3,694 |
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Dear Helmut, Many thanks by your prompt response. Is there any legislation or source that corroborates this? Best regards, |
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Helmut ★★★ Vienna, Austria, 2020-10-01 19:02 (1446 d 08:58 ago) @ Brus Posting: # 21960 Views: 3,674 |
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Hi Brus, ❝ Is there any legislation or source that corroborates this? That’s what I’ve heard from my clients. Maybe there is some legislation; dunno. Let’s wait for our Russian colleagues to chime in. — 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 |
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Beholder ★ Russia, 2020-10-02 11:24 (1445 d 16:36 ago) @ Helmut Posting: # 21963 Views: 3,629 |
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Dear Brus and Helmut, I know for sure that it is possible to conduct bioanalytics and PK assessment outside of Russia. I saw many times such situation within my 8-years experience. Regarding the source. There is no exact wording in the laws that it is possible to conduct bioanalytics and PK assessment outside of Russia. But from experience it is so. You may also look at this doc from 2012 (it presents the EPRD analysis of clinical trials system in Russia and compares it to EU system in some cases). Not lots of things have been changed since 2012  . Just search for word "local" and you will see that there was no any exact reference to law found even by EPRD. The necessity to conduct clinical trials is written indirectly in FZ 61:"5. In the Russian Federation, in accordance with international treaties of the Russian Federation and / or on the basis of the principle of reciprocity, the results of clinical trials of medicinal products for medical use conducted outside the territory of the Russian Federation are recognized.". But Russia has no any international treaties and no one recognize the clinical trials conducted in Russia. So it means that you need local clinical trial conducted in Russia. — Best regards Beholder |
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Beholder ★ Russia, 2020-10-03 21:51 (1444 d 06:09 ago) @ Brus Posting: # 21967 Views: 3,444 |
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Hi Brus! An idea visited my mind. The permission for clinical trial in Russia does not contain the information regarding analytical/PK part of the study at all. It talks only about clinical part of BEQ project. So in Russia we can say that clinical study = clical part of BEQ study. So it means that only clinical part has to be conducted in Russia. Again indirect prove but only this we have. Hope it helps. — Best regards Beholder |
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Brus ★ Spain, 2020-10-21 12:42 (1426 d 15:17 ago) @ Beholder Posting: # 22042 Views: 2,872 |
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Dear Beholder, Excuse me for insisting on this issue, but with the creation of the EAEU (2016 aprox) and Russia being part of it, FL 61 will be replaced by the EAEU's own laws in 2025. In fact if I'm not wrong, national NDA will no longer be able to be submitted, instead, "MRP" or "DCP" of the EAEU will have to be submitted. The general law for medicines in the EAEU is Decision No. 78 On the Rules of marketing authorization and assessment of medicinal products for medical use. It specifies the following regarding clinical trials sites: Within the procedure of granting a marketing authorization for a medicinal product, the clinical study reports included in the Module 5 of the marketing authorization application dossier shall be taken into account in the assessment subject to either of the following conditions:
not complied with, before applying for the marketing authorization for a medicinal product, the applicant must conduct clinical trials (at least one trial at the applicant’s disposal and as agreed with the competent authority) fully or in part within the Union, or the competent authority shall trigger an unscheduled inspection of one clinical trial site where the trial has been conducted, within the assessment of the marketing authorization application dossier. From what I understand it is now possible, in the context of EAEU and no longer FL61, to execute the entire clinical trial outside of Russia or EAEU. What is your opinion? Or is that just the theory but in practice clinical trials are executed in Russia or EAEU? Do you know what is the usual practice? Best regards, |
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Ohlbe ★★★ France, 2015-03-27 10:52 (3461 d 16:07 ago) @ Anand Posting: # 14622 Views: 6,912 |
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Dear Anand, ❝ BABE Forum Russia that link not working. Hence Please provide BE Guideline & Requirement in Russia Link ??? Just checked, the links are working. — Regards Ohlbe |
Ing. Helmut Schütz