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

Highlights: this month, two innovative drugs of chemical medicine category 1 have submitted applications for listing This month, 61 acceptance numbers were added according to the quality and efficacy consistency evaluation varieties of generic drugs According to the latest statistics of drug intelligence database, in August 2018, CDE undertook 617 new drug registration applications with acceptance number (excluding reexamination, the same below) (Figure 1) from January to August 2018, the total acceptance of CDE drugs in this month has declined from the peak in July, down 15.5% month on month compared with July Among them, 506 are accepted for chemical medicine, 21 for traditional Chinese medicine, 66 for biological products, 8 for medical packaging materials, 6 for medical auxiliary materials and 6 for raw materials Let's analyze the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products Statement: this opinion only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.