Full
Outline
AbstractThe new edition of the Good Clinical Practice (GCP) was officially issued on June 8, 2026. It fully incorporates the core principles of the ICH guideline E6(R3): Guideline for Good Clinical Practice and fundamentally reshapes the clinical trial safety review system. Through a comparative analysis of the 2026 and 2020 versions of the GCP, and with reference to supporting documents such as the Technical Guidance on the Collection, Analysis, and Reporting of Expedited Safety Reports by Sponsors During Clinical Trials (Draft for Comment) (2026), this study provides an in-depth analysis of the key changes and underlying logic of the safety review under the new regulations. The study concludes that the new regulations comprehensively introduce the concept of “risk-proportionality,” further optimizing the safety reporting mechanism, the content of safety reviews, and the approaches of safety review, while clarifying the responsibilities of relevant parties. To adapt to these changes, safety reviews under the new regulations should establish an ethics review system aligned with the new requirements by strengthening the review capabilities of ethics committee members, optimizing review procedures, refining the content and requirements of safety reviews, and enhancing multi-stakeholder collaboration.
64
9
| 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 |
关闭全屏
No. 86 Xueyuan South Road, Haidian District, Beijing
010-62662699(Operation and Technical Support)
qkjq@cast.org.cn
Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House
