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The situation of new drug approval by the State Drug Administration (NMPA) from 2016 to 2020 was systematically analyzed and compared with that by the Food and Drug Admin-istration (FDA) of the United States in the same period, the trend of drug R&D in China in the past five years was analyzed, and the trend of new drug R&D and approval in China from 2016 to 2020 were summarized. Combined with China's drug administrative supervision and management regulations, the status and role of China in global drug R&D were analyzed. It was found that a total of 956 new drug applications (NDA) were approved by NMPA from 2016 to 2020, including 471 for chemicals, 235 for traditional Chinese medicine, and 250 for biopharmaceuticals. The number of new drugs approved by NMPA continued to increase in the 5 years. Compared with the application and approval of FDA, the number of drugs de-clared in China was larger, but the proportion of approval was smaller, the number of first-class innovative drugs was smaller, the main indications for approved listed drugs were anti-tumor, digestive system and anti-infection, and the R&D of drugs for rare diseases and orphans were insufficient. The number of approved new drugs in China was increasing year by year, but the proportion of local original research and new drugs was relatively small, basic research and transformation research was weak, and the R&D of new target molecular drugs was not enough.
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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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