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ICH M4Q(R2): List of comments published
Recommendation
6/7 October 2026
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In mid-February 2026, a summary of the comments received during the public consultation on the "ICH M4Q(R2) Guideline on the Common Technical Document for the registration of pharmaceuticals for human use: Quality" was published on the EMA website. This guideline is currently in "Step 2" of the update procedure, and the comments received are now being reviewed in "Step 3" of the ICH procedure.
The list of comments is 145 pages long and divided into two main sections, which are listed below:
1. General comments - overview
2. Specific comments on text
In addition to the comments and requested changes, the list includes the names of the companies that submitted comments and requested changes, the relevant sections of the guideline and the exact text passages concerned.
The draft document "ICH M4Q(R2) Guideline on the Common Technical Document for the registration of pharmaceuticals for human use: Quality" and the comments can be found on the EMA website.
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