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The evolution of the ICH E6(R3) guideline heralds a new era for global Good Clinical Practice (GCP), centered on "participant-centricity" and "Quality by Design". From the perspective of China′s clinical trial regulatory inspection, this article provides a systematic comparative analysis of the transformative changes introduced by E6(R3) versus E6(R2) across seven key dimensions: core principles, trial design, ethical review, safety monitoring, vendor management, sponsor quality management, and data governance. The study concludes that these changes necessitate a fundamental paradigm shift in China′s registration inspection approach—moving from traditional "compliance verification" to an in-depth "assessment of system effectiveness" and "design rationality". To address this challenge, regulatory authorities must take the lead in comprehensively upgrading inspection philosophies, inspector competencies, technical tools, and evaluation standards. This will guide the clinical trial ecosystem in China towards high-quality and sustainable development, ensuring the effective protection of participants′ rights, safety, and welfare.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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