Submission of 'failed' studies [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2009-08-31 17:36 (5644 d 08:40 ago) – Posting: # 4138
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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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