Full
Outline
To conduct a comprehensive analysis of drugs marketed through the conditional approval process in China from 2020 to 2024, along with recommendations for improving this process.
Drugs conditionally approved during the study period were identified through the National Medical Products Administration public data, the Center for Drug Evaluation public data, and the Yaozhi Database. The basic information, pre-market clinical trial studies, and post-marketing study requirements and progress were collected and analyzed.
A total of 143 approved matters were marketed through the conditional approval process. Key characteristics included: R&D resources were highly concentrated on antineoplastic drugs, a high percentage of applications in pre-market pivotal clinical trials were based on surrogate endpoints, and the conversion rate of drugs from conditional approval to full approval was low.
It is necessary to strengthen the guidance provided by drug regulatory and relevant departments, establish a system for recognizing surrogate endpoints, and improve the flexibility of the conditional approval process.
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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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