Bioequivalence and Bioavailability Forum • Submission of 'failed' studies

Submission of 'failed' studies [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2009-08-31 17:36 (6137 d 14:44 ago) – Posting: # 4138
Views: 6,532

Dear Ohlbe!

❝ Independently of the guideline, for EU submissions Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, requires that all clinical trials conducted on the product be submitted, whether positive or negative.

❝

❝ A lot of fuss has been made about this paragraph in the draft EU guideline. There was nothing new in it: this requirement is in place since at least 1975 (Annex to Directive 75/318/EC).

Thanks for the information. I didn't know that!
In those ol' days when faxmachines used fanfold thermoprint paper, I was pretty sure that when I was transmitting a 'not-so-nice' drafted report to the sponsor on their side the fax went straight into a document shredder - and the final report to a filing cabinet in the third basement and never saw daylight again...

P.S.: 75/318/EC, Annex I to 2001/83/EC, Annex I to 2003/63/EC.

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Complete thread:

Fed-fasted BE studies using different polymorphs london12 2009-08-25 14:21
- Fed-fasted BE studies using different polymorphs Helmut 2009-08-27 00:44
  - Fed-fasted BE studies using different polymorphs Ohlbe 2009-08-31 01:34
    - Submission of 'failed' studiesHelmut 2009-08-31 15:36
      - Submission of 'failed' studies Ohlbe 2009-08-31 23:01
  - Fed-fasted BE studies using different polymorphs qualityassurance 2023-08-03 10:44