Updated and expanded ICH Q9(R1) Quality Risk Management briefing pack now available

8th April 2026

Summary:
The International Council for Harmonisation (ICH) has released an updated and expanded briefing pack for ICH Q9(R1), providing additional guidance on quality risk management. The materials are designed to help industry and regulators better understand and implement the revised guideline, with a focus on enhancing risk-based decision making across pharmaceutical development and manufacturing. The briefing pack includes practical examples and clarifications to support consistent application, particularly in areas such as formality in risk management processes and risk-based decision making. This update aims to strengthen quality systems and promote more effective, science-led approaches across the product lifecycle.

Link: https://www.ich.org/news/updated-and-expanded-ich-q9r1-quality-risk-management-briefing-pack-now-available

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