ICH updated and expanded Q9(R1) Quality Risk Management Briefing Pack
- Date
- March 23, 2026
- Category
ICH Regulations
- Description
ICH has published an updated and expanded Q9(R1) Quality Risk Management Briefing Pack to support the implementation of a systematic approach to quality risk management (QRM) in pharmaceutical development, manufacturing and distribution.
The updated ICH Q9(R1) Briefing Pack reflects the new guidance on QRM that appears in the revised ICH Q9(R1) Guideline that was finalised in 2023.
The ICH Q9(R1) Briefing Pack contains a new introductory presentation, nine training presentations on QRM methods and tools (reflecting Annex I of the Guideline) and nine training presentations on the potential applications of QRM (reflecting Annex II of the Guideline).
Together, ICH Q9(R1), ICH Q8(R2) and ICH Q10 form a trio of ICH Quality Guidelines that encourage the further development of science- and risk-based approaches to quality. The new ICH Q9(R1) Briefing Pack contributes to a body of training materials that helps stakeholders understand and apply the principles and guidance set out in the ICH Q9(R1) Guideline, and the training materials on the implementation of Q9(R1), Q8(R2) and Q10 illustrate how the three Guidelines work together as part of a lifecycle framework for an effective Pharmaceutical Quality System. The ultimate goal is to protect patients.