[exclusive] analysis report on CDE drug review in July 2018

Spot A kind of This month, the total acceptance volume of the drug Audit Center reached a new high A kind of Jiangsu Haosen heavyweight innovative drug - flumatinib mesylate tablets submitted an application for listing A kind of The fifth batch of approved generic drugs have been released by the State Drug Administration According to the latest statistics of drug intelligence database, in July 2018, CDE undertook 730 new drug registration applications with acceptance number (excluding reexamination, the same below) The total acceptance volume of this month has kept rising for four consecutive months, increasing by 12.1% compared with June, including 600 chemical drugs, 40 traditional Chinese medicines, 65 biological products, 12 medical packaging materials, 5 pharmaceutical excipients, 7 APIs and 1 in vitro diagnostic reagent Let's analyze the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products This month, the State Drug Administration released the fifth batch of generic drugs approved for conformity assessment of quality and efficacy, with a total of 16 varieties As of July 31, 2018, a total of 57 acceptance numbers have been announced to have passed the consistency evaluation (if you need to query the varieties that have passed the consistency evaluation in advance, please pay attention to the registration and acceptance database of smart drugs), including 29 varieties, 23 specifications belong to 289 base drug catalog, and 34 specifications belong to non 289 base drug catalog In July, 36 acceptance numbers were added, including 10 injection acceptance numbers Click here to enter the registration and acceptance database of smart drugs for more details!