The Center for Drug Evaluation (CDE) released its 2024 annual drug review report, highlighting continued growth in drug regulatory filings. The CDE accepted a total of 19,563 filings of various types, marking a 5.73% year-on-year increase.
Filings Breakdown
The filings included 17,476 for drug preparations, up 3.42% YOY, and 2,087 for chemical raw materials, up 30.03% YOY. Among these, 2,158 filings did not require technical review for direct administrative approval. A total of 15,318 cases required technical review, representing a 16.46% YOY increase.
Review Completion
In 2024, the CDE completed the review of 18,259 filings for various drug types, a 16.20% YOY increase. This included 16,117 drug preparation filings, up 10.98% YOY, and 2,142 chemical raw material filings, up 80.00% YOY. The 16,117 drug preparation filings consisted of 13,913 technical review filings, up 30.74% YOY, and 2,204 direct administrative approval filings.
Communication and Exchange Services
The CDE received a total of 5,554 filings for communication and exchange meetings, processed 4,912 filings for such meetings, and provided communication and exchange services for 3,551 varieties from 1,575 enterprises. A total of 691 face-to-face meetings and telephone conferences were held, up 12.91% YOY.-Fineline Info & Tech
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