Bioequivalence and Bioavailability Forum

Russia: Toxicity data required [Regulatives / Guidelines]

posted by mittyri  – Russia, 2013-09-02 16:18 (4678 d 04:40 ago) – Posting: # 11407
Views: 11,934

Hi Helmut & Karthikeyan!

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”)

Complete thread:

• Russia Guidance – BE Karthikeyan 2013-09-02 05:55 
  • 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
  • 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
        • Russia Guidance – BE mittyri 2013-09-04 09:15