CDE: 21% YOY increase in Cat 1 varieties under review last year

The Center for Drug Evaluation (CDE) released the “2019 Drug Reviews and Approvals Report”. The year saw 8,082 approval filings (5 for medical devices) accepted for review by the agency, including 700 Category 1 filings, for 319 drug varieties, up 20.8% year-on-year (YOY). Of those 319 drug varieties, 302 were investigational new drug (IND) filings, up 26.4%; and 17 were new drug applications (NDAs), 8 less than last year.

Acceptance for review: 528 domestic Category 1, covering 244 varieties in cancer, infection and digestive diseases; 157 Category 5.1 imported chemicals for 92 varieties; 172 Category 1 innovative imported drugs for 75 varieties covering cancer, endocrine system and nervous system diseases. 127 Category 1 therapeutic biologic product filings for 100 varieties, up 3.3% YOY; 119 Category 1 therapeutic biologic IND filings for 95 varieties focusing on cancer, accounting for 69% of all Category biologic IND filings.

Concluded cases: The CDE has been improving review and approval efficiency from 2015 to 2018, with over 90% of reviews completed within the specified timeline rate for traditional Chinese medicines (TCMs), chemical, and biologic drugs.

Priority reviews: There were 253 filings for 139 varieties (based on generic names) that were awarded priority review status in 2019, down 19.2% YOY. Among them, 52 were for pediatrics and rare disease drugs, with new drugs offering significant clinical benefit making up the majority at 34%, followed by varieties already approved overseas and filed concurrently in China. A total 28 products were designated as key treatment area varieties, involving cancer, infection, circulation, rheumatism, the nervous system and other treatment areas.

The CDE turbocharged the review and approval of clinically urgent overseas drugs in 2019, with 36 nodded for marketing in China.


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