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Drug review hits a new high, anti-tumor drug research and development leads the way, my country's drug review work in 2024 has achieved outstanding results
2025-05-08 source:CCTV.com

CCTV News: The State Food and Drug Administration released the "2024 Annual Drug Review Report" on March 18. The report shows that in 2024, China approved 48 Class 1 innovative drugs throughout the year, covering nearly 20 treatment areas such as tumors, neurological diseases, endocrine system diseases and anti-infection. A large number of new and good drugs are accelerating their benefits to patients.

Yuan Lijia, Business Administration Office of the Drug Review Center of the State Food and Drug Administration, said that in 2024, the State Food and Drug Administration included 124 applications for priority review and registration involving 88 varieties, an increase of more than 14% year-on-year. In 2024, the State Food and Drug Administration completed the priority review and approval procedures and 110 drug registration applications were applied for, involving 74 varieties and increased by more than 29% year-on-year.

Since the implementation of the "Drug Registration Management Measures" in 2020, a total of 496 drug registration applications have been included in the priority review and approval procedures, including anti-tumor drugs, dermatological and enthalpy drugs, endocrine system drugs, etc., among which anti-tumor drugs account for the largest proportion, at 42.54%.

The report shows that in 2024, the State Food and Drug Administration accelerates the approval and launch of drugs for urgently needed drugs such as innovative drugs, rare disease drugs and children's drugs: 48 varieties of Class 1 are approved, of which 17 varieties are approved for marketing through the priority review and approval procedures, 11 varieties are approved for marketing with conditions, and 13 varieties are included in the breakthrough therapeutic drug procedure during the clinical trial period; 55 varieties of rare disease drugs are approved (not including 4 generic drugs for chemical drugs), of which 20 varieties are accelerated for marketing through the priority review and approval procedures, and 2 varieties are approved for marketing with conditions; 106 varieties are approved for marketing with conditions; 71 marketing authorization applications are approved, of which 20 varieties are accelerated for marketing through the priority review and approval procedures; 35 varieties are approved to expand the indications of children, greatly alleviating the selection of pediatric drugs.

In addition to the enhanced medical protection for children, the accessibility of shortage drugs has also been significantly improved. In 2024, the State Food and Drug Administration approved 117 shortages of drugs (21 varieties), and a total of 226 approved in the past five years, covering 12 areas such as circulation and nerves.

In terms of breakthrough therapeutic drug procedures, the State Food and Drug Administration received a total of 337 applications in 2024 and agreed to include 91 (84 indications), an increase of 30% year-on-year. Since the implementation of the "Drug Registration Management Measures" in 2020, a total of 294 breakthrough therapeutic drug procedures (246 indications) have been included, and the top three are anti-tumor drugs, neurological disease drugs and anti-infective drugs.

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