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To provide practical references for all participants in drug clinical trials on drug safety risk management and promote the construction of a more efficient clinical trial safety management system.
Based on the regulatory practice of 40 clinical trial safety risk control cases from the Center for Drug Evaluation in 2024, this paper uses classified statistics and correlation analysis methods to analyze the characteristics of safety risk information from multiple dimensions such as drug types and indications, and systematically sorts out the response logic of regulatory measures.
Among the 40 cases where risk management procedures were initiated, distinct risk characteristics were observed across different drug types and indications. The regulatory measures reflected the principle of matching the intensity of control with the risk characteristics.
Regulatory authorities have adopted differentiated regulatory requirements in accordance with the logic of risk classification and bottom-line thinking. The regulatory initiatives have gradually evolved into focusing on the optimization and full-chain improvement of sponsors’ risk management systems, providing crucial support for the protection of subjects’ rights and interests as well as the high-quality development of pharmaceutical innovation..
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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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