ICH (E6) R2 Addendum – Step 4

by | Dec 8, 2016 | Industry Focus, Regulatory Focus

The ICH E6 (R2) has been formally adopted by the ICH assembly held in Osaka, Japan on 5-10 November 2016.
All changes proposed in ICH E6 (R2) Step 2 have been accepted in principle, within the ICH E6 (R2) guideline during Step 4 adoption by the ICH Assembly. A detailed summary of the few minor differences from the Step 2 revision can be downloaded here.
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