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RegisterRussia: Toxicity data required [Regulatives / Guidelines]
Hi Helmut & Karthikeyan!
Helmut knows (almost) everything
At this moment - yes. I would pay your attention on new amends prepared by MoH and experts. They are going to be approved soon.
According to this draft it will be allowed only to post a literature review of originator's preclinical trials.
It's discussed now about data exclusivity of this data. May be it would be possible only with originator's permision (or 6 years after Originator's registration)
No one knows how would it works
Helmut knows (almost) everything
❝ ❝ i am in need of information, whether that is sufficient or we need additional toxicity or clinical trials...
❝ You need toxicity data of the formulations (test + reference!) – not only of the API – before you start a BE study.
At this moment - yes. I would pay your attention on new amends prepared by MoH and experts. They are going to be approved soon.
According to this draft it will be allowed only to post a literature review of originator's preclinical trials.
It's discussed now about data exclusivity of this data. May be it would be possible only with originator's permision (or 6 years after Originator's registration)
No one knows how would it works
❝ Anyhow, according to federal law #61 (aka “Lex Putin”)
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- Russia Guidance – BE Karthikeyan 2013-09-02 05:55
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Russia Guidance – BE drgunasakaran1 2013-09-02 06:14
- Russia Guidance – BE Karthikeyan 2013-09-02 06:21
- Russia: Toxicity data required Helmut 2013-09-02 10:31
- Russia: Toxicity data requiredmittyri 2013-09-02 14:18
- Russia: Toxicity data required Karthikeyan 2013-09-03 08:48
- Russia: Toxicity data required mittyri 2013-09-03 09:26
- Toxicity data: why? Helmut 2013-09-03 13:02
- Russia: Toxicity data required Karthikeyan 2013-09-04 06:46
- Russia: Toxicity data required mittyri 2013-09-04 08:58
- Federal Law # 61–FZ “On circulation of drugs” Helmut 2013-09-05 00:09
- Federal Law # 61–FZ “On circulation of drugs” Karthikeyan 2013-09-05 13:52
- # 61–FZ adopted 24 March 2010 Helmut 2013-09-05 15:21
- # 61–FZ adopted 24 March 2010 Karthikeyan 2013-09-06 06:32
- # 61–FZ adopted 24 March 2010 mittyri 2013-09-06 07:22
- # 61–FZ adopted 24 March 2010 Karthikeyan 2013-09-06 06:32
- # 61–FZ adopted 24 March 2010 Helmut 2013-09-05 15:21
- Federal Law # 61–FZ “On circulation of drugs” Karthikeyan 2013-09-05 13:52
- Federal Law # 61–FZ “On circulation of drugs” Helmut 2013-09-05 00:09
- Russia: Toxicity data required mittyri 2013-09-04 08:58
- Russia: Toxicity data required mittyri 2013-09-03 09:26
- Russia: Toxicity data required Karthikeyan 2013-09-03 08:48
- Russia: Toxicity data requiredmittyri 2013-09-02 14:18
- Russia: Toxicity data required Helmut 2013-09-02 10:31
- Russia Guidance – BE Karthikeyan 2013-09-02 06:21
- Russia Guidance – BE Dr_Dan 2013-09-03 14:40
- Russia Guidance – BE Helmut 2013-09-03 14:45
- Russia Guidance – BE Dr_Dan 2013-09-03 19:27
- ги́бкость Helmut 2013-09-03 21:16
- Flexibility Dr_Dan 2013-09-04 10:20
- Cultural ∆ Helmut 2013-09-04 14:30
- Flexibility Dr_Dan 2013-09-04 10:20
- Russia Guidance – BE mittyri 2013-09-04 09:15
- ги́бкость Helmut 2013-09-03 21:16
- Russia Guidance – BE Dr_Dan 2013-09-03 19:27
- Russia Guidance – BE Helmut 2013-09-03 14:45
- Russia Guidance – BE drgunasakaran1 2013-09-02 06:14
Ing. Helmut Schütz