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On April 20, the State Food and Drug Administration issued the "Annual Report on Drug Administration Statistics (2020)".
The report shows that in 2020, the State Food and Drug Administration will accept 587 imported clinical trial applications and 3397 applications for supplementary approval in provinces and cities; 1,096 innovative drugs have been approved for clinical use, and 20 innovative drugs have been approved for production, of which only 2 are biological products; 879 new drugs have been clinically approved, including 9 Chinese natural medicines.
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The report shows that in 2020, the State Food and Drug Administration will accept 587 imported clinical trial applications and 3397 applications for supplementary approval in provinces and cities; 1,096 innovative drugs have been approved for clinical use, and 20 innovative drugs have been approved for production, of which only 2 are biological products; 879 new drugs have been clinically approved, including 9 Chinese natural medicines.
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Drug Administration Acceptance Situation
Drug Administration Acceptance Situation587 imported clinical trial applications accepted
587 imported clinical trial applications accepted3397 provincial and municipal supplementary approval applications
The report shows that in 2020, the National Bureau will accept 587 clinical trial applications for imported drugs (including Hong Kong, Macao and Taiwan), 300 marketing applications, 320 re-registration applications, and 3685 supplementary applications; 1099 clinical trial applications for domestic drugs and 1076 marketing applications will be accepted , 1520 supplementary applications; 881 applications for quality and efficacy consistency evaluation of generic drugs and 489 temporary import applications were accepted.
In 2020, provincial (autonomous regions and municipalities) bureaus received 3397 applications for supplementary drug approval, 25,638 applications for supplementary drug filing, and 90094 applications for re-registration.
108 first-time applications for imported medicinal materials, 337 non-first-time applications, and 6 supplementary applications were accepted.
Drug registration approval status
879 new drugs were clinically approved, and biopharmaceuticals accounted for 223
According to the report, in 2020, the State Food and Drug Administration approved a total of 879 clinical applications for new drugs (excluding imported drugs), including 9 natural Chinese medicines, 647 chemical drugs, and 223 biological products; a total of 181 clinical applications were approved according to the new drug application procedures.
Among them, 11 are traditional Chinese medicines and natural medicines, 97 are chemical medicines, and 73 are biological products.
In 2020, a total of 1,096 clinical varieties of innovative drugs have been approved, and 20 production varieties of innovative drugs have been approved.
In 2020, a total of 604 clinical imported medicines were approved, including 223 biological products, 380 chemical medicines, and 1 Chinese medicine natural medicine; in addition, 128 will be approved for marketing, with 49 biological products and 79 chemical medicines.
722 generic drugs approved clinically
In 2020, a total of 41 generic drugs were approved for clinical trials, and 722 were produced.
For more details, please check the original report:
