ICH published updated Q8/Q9/Q10 Questions & Answers Document
Recommendation
10/11 February 2026
Heidelberg, Germany
Medicinal Products/Drugs meet Medical Devices
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
The ICH Secretariat announced the publication of the updated Q9(R1) Annex 1- Q8/Q9/Q10 Questions & Answers (R5) related to ICH Q9(R1) Quality Risk Management (QRM). The ICH Assembly approved the updated Annex on 30 October 2024.
The Q&As have been updated by removing outdated text and rephrasing the Q&As considered in view of the implementation of ICH Q8, Q9 and Q10, with minor additions to address minor content gaps in the document. Furthermore, minor edits have been made to improve the readability of the document.
Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the ICH Q8(R2), Q9 and Q10 Guidelines have resulted in the need for some clarification. The Questions and Answers developed by the Quality Implementation Working Group (IWG) are intended to facilitate the implementation of the Guidelines, by clarifying key issues.
Besides the core topics Pharmaceutical Development, Quality Risk Management, Pharmaceutical Quality Systems, the topic of Knowledge Management is further elaborated and how the implementation of ICH Q8, Q9, and Q10 has changed the significance and use of knowledge management.
Related GMP News
04.02.2026When Training Falls Short: FDA Findings on GMP Training Deficiencies in 2025
27.01.2026New Ph. Eur. Publication Schedule
21.01.2026EU Pharma Package: EMA with single Point of Information
14.01.2026European QP Association Developments September through December 2025
14.01.2026Could a change of ownership be relevant to GMP?
07.01.2026Is QP Certification required when Products do not enter EU Territory?