20/21 March 2024
Since the end of last year, the ICH Q9 document on quality risk management has been in stage 2 of the ICH process for publishing ICH documents as a draft revision 1. Now, the draft document has also been published by the FDA on its website and is available for comments.
Under Draft revision of ICH Q9 Quality Risk Management Guideline published you could already read about the ICH Q9 draft document - as well as about the comments provided by an ECA Expert Group; see Comments on the new ICH Q9 Guideline Q9 (Quality Risk Management) published.
The FDA has now also published the draft document on its website as "Draft Guidance for Industry" dated 14 June 2022. Comments on the draft document can be submitted online or in writing to the FDA.
You can find the FDA information at Q9(R1) Quality Risk Management on the FDA website.