Bioequivalence and Bioavailability Forum

Russian GL 2013: harmonisation to EMA [Regulatives / Guidelines]

posted by mittyri  – Russia, 2013-12-14 12:57 (4571 d 03:40 ago) – Posting: # 12058
Views: 31,375

Hi, Helmut!

❝ • BTW, in Russia an AR of 75–133% for C_max is acceptable for all drugs without a clinical justification, right?[/list]

Changes are coming...
Scientific Center for Expertise of Medical Products (regmed.ru) has published a new Guideline for drugs Expertise this year. Meanwhile you cannot find this GL on the site. Why?
They published a book! I think that's a perfect decision!

The chapter about the statistics in BEQ studies is a good translation of EMA GL 2010. So at this moment we are closer to the European requirements than ever.
There's only one difference: biowaiver procedure is not mentioned and not approved.

Are you thinking that harmonisation is finished?
That's too easy!
GL 2013 is not approved by MoH! No one can say what kind of GL should we use in preparing our studies - 2004 (approved by MoH), 2008 or 2013. All of them are acceptable till MoH will finally approve new GL...

PS If anyone have additional information - please correct me.
I'm waiting for a good analytical post with a comparison of the past and new requirements from my colleague Beholder

Complete thread:

• Bioequivalence Recommendations for Specific Pro­ducts cr.maroj 2013-09-19 11:00 [Regulatives / Guidelines] 
  • Bioequivalence Recommendations for Specific Pro­ducts Ohlbe 2013-09-19 11:45
    • EMA: Draft product-specific guidances ♬ Helmut 2013-11-15 15:45
      • EMA: Draft product-specific guidances ♬ luvblooms 2013-11-19 06:35
      • EMA: Capecitabine product-specific guidance ♬ mittyri 2013-12-10 15:33
        • EMA: Capecitabine product-specific guidance ♬ Helmut 2013-12-10 16:11
          • Russian GL 2013: harmonisation to EMAmittyri 2013-12-14 11:57
      • EMA: Draft product-specific guidances ♬ pash413 2013-12-18 12:35
        • EMA: Use of AUC72 not dependent on t½ Helmut 2013-12-18 14:35
      • End of consultation approaching‼ Helmut 2014-02-10 18:33
        • End of consultation approaching‼ Dr_Dan 2016-01-28 09:27
          • Guesstimates Helmut 2016-01-28 13:32
  • EMA: generally no product-specific GLs Helmut 2013-09-19 11:48
    • Thank you cr.maroj 2013-09-19 13:03
    • EMA: generally no product-specific GLs The Outlaw Torn 2013-09-20 07:52
      • EMA: parent whenever possible Helmut 2013-09-20 09:02
        • EMA: parent whenever possible cr.maroj 2013-09-20 10:14
          • EMA: parent whenever possible Helmut 2013-09-20 12:53
            • EMA: parent whenever possible Ohlbe 2013-09-20 13:52
              • EMA: parent whenever possible mittyri 2013-09-20 14:55
                • EMA vs. Russia Helmut 2013-09-20 19:21
                  • FDA: Prasugrel intuitivepharma 2013-12-20 07:36
                    • FDA: Prasugrel Helmut 2013-12-20 13:46
                      • FDA: Prasugrel intuitivepharma 2013-12-24 06:38
                        • FDA: Alternative approaches… Helmut 2013-12-24 14:15
                          • FDA: Alternative approaches… intuitivepharma 2013-12-26 05:11
                            • FDA: RTR Helmut 2013-12-26 14:35
                              • FDA: RTR intuitivepharma 2013-12-31 05:34
                              • FDA: RTR meghalvakil20 2015-07-23 16:32
                                • WayBack Machine Helmut 2015-07-23 16:58
                                  • WayBack Machine meghalvakil20 2015-07-23 17:03
                                    • Old stuff Helmut 2015-07-23 17:28
                • EMA: parent whenever possible ElMaestro 2013-09-20 19:35
                  • EMA: Sirolimus product-specific GL luvblooms 2013-11-19 13:00