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Welcome to CQAF

The China QA Forum (CQAF) was set up in May 2010 and is a Leading Quality Assurance Platform in China aiming to promote GxP Quality Standards in the Healthcare Industry.

For more, click About CQAF

Meeting

1 .2026.09.12 | Inviting you to CLQA 2026 Q3 Meeting

2 .2026.05.31 | CLQA 2026 Q2 Meeting

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Training

1 .General Principles of Records and Information Mgmt

2 .Quality Mgmt in China GCP institution

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Publications

1 .从CRC现况看研究者团队的真实履职

2 .临床试验研究中心选择

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Newsletters

1 .“New to Quality” 第五期——聚焦流程管理，夯实临床试验质量体系执行根基

2 .“New to Quality” 第四期——供应商管理

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News

1 .重塑质量，向新而行——2026中国质量保证论坛（CQAF）年会

2 .从模型到证据系统：AIM-MASH的FDA资格认定与质量管理启示

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Regulatory Express

1 .Regulatory Express_Oct. 2026

2 .Regulatory Express_July 2026

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Mentor/Mentee

1 .Regulatory Express_Oct. 2026

2 .Regulatory Express_July 2026

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Buddy Coach

1 .Regulatory Express_Oct. 2026

2 .Regulatory Express_July 2026

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News

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Regulatory Express_Oct. 2026
2026-10-21 22:05:20

The International Council for Harmonization (ICH) has announced the adoption of Annex 2 to the guideline on Good Clinical Practices (GCPs) E6(R3). This annex focuses on the collection of data from a wider range of sources for clinical trials, including decentralized trials and pragmatic clinical trials (PCTs). The finalized version of Annex 2 does not include any major changes from the draft guideline issued in November 2024.
重塑质量，向新而行——2026中国质量保证论坛（CQAF）年会
2026-10-20 22:12:19

让质量成为创新时代最可信赖的力量。这是一次关于未来的讨论。我们期待与更多同行者一起，在坚守中传承初心，在创新中创造价值。
从模型到证据系统：AIM-MASH的FDA资格认定与质量管理启示
2026-09-02 21:35:53

本案例由 AI in cQMS 亚组：AI发展趋势追踪与案例研究工作组整理完成。 AI发展趋势追踪与案例研究工作组的定位是追踪AI在药物研发、监管与企业运营中的应用案例，分析其对质量管理的启发，以帮助质量管理从业者理解AI正在改变什么，以及对质量管理意味着什么。

Useful Link

Regulatory Authority

Industry Association