ICH发布新版Q8/Q9/Q10问答文件

2024年12月6日，ICH秘书处宣布发布更新的与ICH Q9（R1）质量风险管理（QRM）相关的《Q9（R1）附录1-Q8/Q9/Q10问答（R5）》。ICH大会于2024年10月30日批准了更新后的附录。

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.

根据ICH Q8、Q9和Q10的实施，问答部分已进行了更新，删除了过时的文本，重新措辞了问答部分，并略微增加了一些内容，以解决文件中的微小内容空白。此外，还进行了微小的编辑，以提高文档的可读性。

The Q&As have been updated by removing outdated text and rephrasing the Q&As considered in view of the implementation of ICH Q8, Q9 and Q10, with minor additions to address minor content gaps in the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.

自达到第4步并在ICH区域内发布以来，各方在实施ICH Q8（R2）、Q9和Q10指南方面的经验使得需要进行一些澄清。质量实施工作组（IWG）制定的问答旨在通过澄清关键问题，促进指南的实施。

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.

除了核心主题药物开发、质量风险管理、药物质量体系外，进一步阐述了知识管理的主题，以及ICH Q8、Q9和Q10的实施如何改变了知识管理的意义和使用。

Besides the core topics Pharmaceutical Development, Quality Risk Management, Pharmaceutical Quality Systems, the topic ofKnowledge Management is further elaborated and how the implementation of ICH Q8, Q9, and Q10 has changed the significance and use of knowledge management.