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To analyze the absolute lag and relative lag time of new drug approvals in China from 2011 to 2021 and reasons causing the lag, and to preliminarily explore the potential factors that affect the new drug launch lag.
The information on new drugs approved for marketing in China, the United States, the European Union and Japan was collected from 2011 to 2021. The durations between the time when the new drugs approved for marketing in China were first approved for marketing in the world were calculated to analyze absolute lag and relative lag in China. Multiple regression analysis was used to determine the factors related to drug lag.
During the period from 2011 to 2021, a total of 280 new drugs were approved in China, among which 180, 82 and 154 drugs exist absolute lags with the United States, the European Union and Japan, respectively. The median duration of the overall relative lag was 1 359 days. The median length of the lag gradually increased from 2011 to 2014, and reached a peak (3 438 days) in 2014; the median length dropped significantly from 2015 to 2018; the median length in 2019 to 2021 decreased year by year. The overall lag in 2020 and 2021 were below the overall median lag, 1 134 days and 500 days respectively (B=-1 153.840, P<0.05). New drugs in theraprutic area of sensory organs were related to a shorter median approval lag, and new drugs of orphan drug designation (B=441.147, P<0.01) and classified as biological products (B=502.205, P<0.01) were related to a longer median approval lag.
In the past years of 2011—2021, the drug lag issue in China has been significantly improved, but the lag phenomenon still exists in new drugs in various therapeutic fields. Under the background of the new policy implement, key factors to reduce the delay in the launch of new drugs include further improving the quality and efficiency of new drug review and approval, strengthening the communication between government approval agencies and applying companies, connecting with international common rules, and encouraging companies to conduct international multi-center clinical trials.
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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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