China: ICH Q9(R1) Annex 1 – Q8, Q9 & Q10 Questions & Answers (R5)

The CDE (NMPA) has opened public consultation on the Chinese translation of ICH Q9(R1) Annex 1: Q8, Q9 & Q10 Questions & Answers (R5), open until November 30, 2025.
Developed by the International Council for Harmonisation (ICH), the document clarifies core concepts from:

• ICH Q8 – Pharmaceutical Development: Focuses on Quality by Design (QbD) and establishing a robust design space.
• ICH Q9 – Quality Risk Management: Guides systematic assessment and control of quality risks.
• ICH Q10 – Pharmaceutical Quality System (PQS): Promotes lifecycle management and continual improvement.

Key highlights:

• Explains Design Space, Control Strategy, and Real-Time Release Testing (RTRT)
• Reinforces Knowledge Management and risk-based process validation
• Confirms ICH does not endorse commercial software tools
• Links Q8–Q10 to inspection practices and continual improvement

This update strengthens China’s alignment with global ICH quality frameworks, fostering consistency and transparency in pharmaceutical manufacturing.