Bioequivalence and Bioavailability Forum

EU Article 31 referral started [GxP / QC / QA]

posted by Ohlbe – France, 2022-01-24 17:47 (163 d 22:59 ago) – Posting: # 22754
Views: 1,608

Dear all,

» Europe: it should not take them more than a year or two to decide what to do

Mmmm. It looks like things are moving a bit: according to the Agenda of the January CHMP meeting an Article 31 referral is being triggered (see page 32 of the PDF). Will take some more months before the referral is concluded and the Commission decision gets published and implemented.

Malaysia announced their decision almost 2 months ago.

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Edit: detailed information on the referral is now available here [Ohlbe].

Complete thread:

• Another two... Ohlbe 2021-09-16 23:41 [GxP / QC / QA] 
  • Another two... ElMaestro 2021-09-17 08:42
    • Dates Ohlbe 2021-09-17 10:15
    • Some more info Ohlbe 2021-09-17 20:28
      • EU Article 31 referral startedOhlbe 2022-01-24 17:47
  • Cheating Helmut 2021-09-17 16:50
    • Increased variability Ohlbe 2021-09-17 17:56
      • Increased variability ElMaestro 2021-09-17 18:51
        • Visualization Helmut 2021-09-18 15:26
  • Another two... jag009 2021-09-19 09:18
  • Another two... ElMaestro 2022-05-24 12:00
    • Blind monitors or greedy sponsors? Helmut 2022-05-24 12:51
      • Blind monitors or greedy sponsors? Ohlbe 2022-05-24 14:21
        • Blind monitors or greedy sponsors? Helmut 2022-05-24 16:35
      • Blind monitors or greedy sponsors? ElMaestro 2022-05-25 08:11
        • (Cumulative) T/R-ratio vs. time Helmut 2022-05-25 09:19
          • Sponsors and CRO selection Ohlbe 2022-05-25 10:53
            • I still think that T/R-ratios are useful Helmut 2022-05-25 12:04
              • T/R-ratios are useful Ohlbe 2022-05-25 14:40
                • T/R-ratios are useful Helmut 2022-05-25 15:35
                • Bust the Buster Helmut 2022-05-26 15:32
                  • complicate the assessor's life mittyri 2022-05-26 18:28
                    • complicate the assessor's life PharmCat 2022-05-27 09:57
                    • complicate the assessor's life Helmut 2022-05-27 10:11
                      • Thanks for Busting the Buster sameep 2022-05-31 08:34
                        • Thanks for Busting the Buster Helmut 2022-05-31 15:22
                          • A small point for the code sameep 2022-06-01 13:17
                            • A small point for the code Helmut 2022-06-01 14:11