CDE's 2024 Annual Drug Review Report Shows Continued Growth in Regulatory Filings

CDE’s 2024 Annual Drug Review Report Shows Continued Growth in Regulatory Filings

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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Insight, China's Pharmaceutical Industry