Anand
☆    

India,
2015-03-27 05:28
(2077 d 01:26 ago)

Posting: # 14619
Views: 6,312
 

 Russia BE Study [Regulatives / Guidelines]

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)
Beholder
★    

Russia,
2015-03-27 09:46
(2076 d 21:08 ago)

@ Anand
Posting: # 14621
Views: 4,921
 

 Russia BE Study

Hello Anand,

According to actual RU GL you has to conduct the local BE study exactly in Russia.

Best regards
Beholder
Anand
☆    

India,
2015-03-27 10:24
(2076 d 20:30 ago)

(edited by Ohlbe on 2015-03-27 11:15)
@ Beholder
Posting: # 14623
Views: 4,918
 

 Russia BE Study

Dear beholder,

Thanks for your reply.

Request to provide,
  1. link Russian BE Guideline & Drug data base search (russia)
  2. If the product already available in russia with two marketed players, then BE Study required & has to be performed in Russia.
Regards,
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]
Beholder
★    

Russia,
2015-03-27 12:21
(2076 d 18:33 ago)

@ Anand
Posting: # 14624
Views: 4,903
 

 Russia BE Study

»  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
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2015-03-27 14:16
(2076 d 16:38 ago)

@ Beholder
Posting: # 14625
Views: 4,986
 

 Red Book?

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.


  • Mironov AN, Kukes VG, Petrov VI, Kuznetsov AL, Goryachev DV, Niyazov RR, Prokofiev AB, Nedogoda SV, Frolov MY, Shnaider A. Investigation of bioequivalence of generic medicinal products. In: Mironov AN (ed). Guidelines for clinical trials of drugs. Part 1. Grif and K, Moscow 2013, pp 175–217.

Dif-tor heh smusma 🖖
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Beholder
★    

Russia,
2015-03-29 16:36
(2074 d 15:18 ago)

@ Helmut
Posting: # 14628
Views: 4,733
 

 Red Book? Yeah...

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
Alyssa
☆    

Malaysia,
2020-10-05 06:00
(58 d 01:53 ago)

@ Beholder
Posting: # 21970
Views: 1,263
 

 Red Book? Yeah...

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.
Beholder
★    

Russia,
2020-10-05 11:34
(57 d 20:20 ago)

@ Alyssa
Posting: # 21971
Views: 1,244
 

 Red Book? Yeah...

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
Brus
☆    

Spain,
2020-10-01 16:05
(61 d 15:49 ago)

@ Beholder
Posting: # 21956
Views: 1,732
 

 Russia BE Study

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,
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2020-10-01 16:47
(61 d 15:07 ago)

@ Brus
Posting: # 21958
Views: 1,720
 

 Russia BE Study

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 🖖
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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Brus
☆    

Spain,
2020-10-01 16:51
(61 d 15:03 ago)

@ Helmut
Posting: # 21959
Views: 1,711
 

 Russia BE Study

Dear Helmut,

Many thanks by your prompt response.

Is there any legislation or source that corroborates this?

Best regards,
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2020-10-01 17:02
(61 d 14:52 ago)

@ Brus
Posting: # 21960
Views: 1,710
 

 Russia BE Study

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 🖖
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Beholder
★    

Russia,
2020-10-02 09:24
(60 d 22:30 ago)

@ Helmut
Posting: # 21963
Views: 1,626
 

 Russia BE Study

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
Beholder
★    

Russia,
2020-10-03 19:51
(59 d 12:03 ago)

@ Brus
Posting: # 21967
Views: 1,447
 

 Russia BE Study

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
Brus
☆    

Spain,
2020-10-21 10:42
(41 d 21:11 ago)

@ Beholder
Posting: # 22042
Views: 874
 

 Russia BE Study

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:
  • the clinical trials had been conducted in compliance with the Member States legislation
    and within their territory before 1 January 2016 (based on the date of the last visit of the last patient (volunteer)) or were being conducted as of 1 January 2016 (the recruitment of the patients (volunteers) into those studies should have been completed by this date)
  • the clinical trials had been conducted in part or fully within the countries of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for
    Human Use (ICH) before 1 January 2016 (based on the date of the last visit of the last patient
    (volunteer)) based on which the medicinal product has been authorized for marketing in the
    countries of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
  • clinical trials commenced after 1 January 2016 have been conducted in compliance with
    the international agreements and acts which constitute the law of the Union and at least one
    clinical study has been conducted fully or in part (as regards of data obtained from the study
    subjects) within the Union.
If the requirements referred to in the second to fourth subparagraphs of this paragraph are
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,
Ohlbe
★★★

France,
2015-03-27 09:52
(2076 d 21:01 ago)

@ Anand
Posting: # 14622
Views: 4,927
 

 Russia BE guidelines

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
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