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In order to encourage clinical value-oriented drug innovation, the current "Drug Registration Regulation" proposes four expedited regulatory approval procedures. For innovative drugs with early clinical trial data that can likely predict the efficacy and clinical benefit of the drugs, the marketing authorization might be granted before the completion of the confirmatory clinical trial through the conditional approval procedure, with all data comprehensively reviewed. By implementing the procedure, patients with serious diseases or conditions can expect more opportunities to prolong their lives or improve their quality of life. Since conditional approval procedures can shorten the time for pre-market clinical research and development, its supporting policies and criteria have attracted much attention. This paper takes the innovative anti-tumor drugs as the starting point, systematically sorts out the policy requirements of conditional approval in China and the criteria that have been formed in the review process, and tries to analyze the problems encountered in the implementation of conditional approval and put forward solutions.
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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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