Bioequivalence and Bioavailability Forum

Russia Guidance – BE [Regulatives / Guidelines]

posted by Karthikeyan – India, 2013-09-02 07:55 (4677 d 23:49 ago) – Posting: # 11400
Views: 12,833

Dear All,

To become generic in Russia, is it enough to perform Bioequivalence study or it needed to perform / provide toxicology or clinical trials data.

please help me out and let me know where i can read the complete requirements.

Regards,

Karthikeyan

Complete thread:

• Russia Guidance – BEKarthikeyan 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 required mittyri 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