## [China: ICH Q9(R1) Annex 1 – Q8, Q9 & Q10 Questions & Answers (R5)](/index%2ephp/mandate/china-ich-q9r1-annex-1-q8-q9-q10-questions-answers-r5) October 31, 2025 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. [Consult Now](/webform/consult?url=https://preprod.freyrsolutions.com/index%2ephp/mandate/china-ich-q9r1-annex-1-q8-q9-q10-questions-answers-r5) Source [https://www.ich.org/news/ich-q9r1-iwg-updated-q9r1-annex-1-q8q9q10-questions-an…](https://www.ich.org/news/ich-q9r1-iwg-updated-q9r1-annex-1-q8q9q10-questions-answers) Select Mandate HA [NMPA](/index%2ephp/mandate-by-ha/nmpa) Select Mandate Function [Regulatory Affairs](/index%2ephp/mandate-by-function/regulatory-affairs)