Bioequivalence and Bioavailability Forum • Russia Guidance

Russia Guidance – BE [Regulatives / Guidelines]

posted by Dr_Dan – Germany, 2013-09-03 16:40 (4677 d 17:52 ago) – Posting: # 11417
Views: 11,926

Dear Karthikeyan
If your product satisfies the criteria of having the same qualitative and quantitative composition in terms of active principles, of having the same pharmaceutical form and of being equivalent then the generic nature is given and it is evident that all data available for the original product also apply for the preparation of your application. The whole information on pharmaco-toxicological and clinical experience can be transferred from the originator product to the Test product. This is the basis for generic applications. Please be advised that information on toxicology refers to the drug entity itself and not to the formulation of a drug. There will be no gain in scientific knowledge if you repeat toxicological tests for your formulation. However, you need to provide evidence that no new toxicologic data are available since marketing authorisation for the reference product was granted.
I hope this helps.
Kind regards
Dan

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

Russia Guidance – BE Karthikeyan 2013-09-02 05:55 [Regulatives / Guidelines]
- 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 – BEDr_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