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Outline
By sorting out the development history, specific content, institutional advantages, and challenges of the complete response letter system in the U.S. evaluation decision feedback mechanism, as well as the current situation of drug evaluation feedback mechanism in China, suggestions for China's evaluation decision feedback mechanism were put forward. The U.S. complete response letter system has certain institutional advantages in improving the transparency of evaluation and guiding applicants' subsequent research and development, thereby contributing to the advancement of the U.S. pharmaceutical industry. China needs to carry out appropriate transformation in combination with its own regulatory practices and external environment. For innovative drugs and other drugs with clinical application prospects, on the premise of informing applicants of "why it is not feasible", further guidance should be provided on "what to do next”; internal evaluation procedures should be optimized to improve the continuity of evaluation; common reasons for rejection of approval should be summarized regularly to provide experience for applicants, avoiding repeated detours; public laws and regulations should be gradually improved to achieve a balance between "disclosure" and "protection”. This article provides references for improving the feedback mechanism of drug evaluation and decision-making in China.
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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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