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Dear Qualityassurance,
It will take a few more months before the guideline comes into force, but it will be applicable to any application submitted after a certain date, even if the trial was done earlier. I would suggest to start getting prepared and to start providing the sponsors with 100% chromatograms.
❝ The ICH guidelines asks for 100% of chromatograms to be submitted. As per EMA and USFDA requirements Chromatograms from 20% of subjects are required.
❝
❝ Should we start submitting 100% chromatograms now.
It will take a few more months before the guideline comes into force, but it will be applicable to any application submitted after a certain date, even if the trial was done earlier. I would suggest to start getting prepared and to start providing the sponsors with 100% chromatograms.
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Publication of the final ICH M10 guideline Ohlbe 2022-06-10 10:48
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Publication of the final ICH M10 guideline qualityassurance 2022-06-12 12:31
- ChromatogramsOhlbe 2022-06-14 11:37
- Publication of the final ICH M10 guideline qualityassurance 2022-06-12 12:31
Ing. Helmut Schütz