Big statistics of CDE drug registration data in 2014

I new declaration 1 Statistics by drug type (1) explanation of traditional statistical caliber If it is not described below, "chemical drugs" includes two parts: preparation and raw materials It can be seen from the figure that the application for registration of chemical medicine is getting stronger and stronger, which can be described as a unique branch (2) separate statistics of preparations and raw materials 2 According to the statistics of application types, supplementary application has always occupied the main position of the congestion army In recent years, new drug application has sprung up, with a momentum exceeding that of generic drugs 3 According to the statistics of the R & D stage, it is obvious that the industry's R & D accumulation time is not long, the vast majority of varieties are in the clinical application stage, and the number of acceptance numbers entering the production reporting stage each year is on the contrary declining Then, the clinical approval varieties are in the Red Sea area, and the valuation will be affected, while the reported product varieties are relatively scarce It needs to be explained that for generic drugs, one should be reported to two batches, and I have made a distinction between the two If we simply treat generic drugs as per the application for production, the result is naturally different from that of me 4 Statistics according to registration and classification (chemical medicine) II Several points need to be explained in the review: A The statistics here omits the auxiliary materials, diagnostic reagents and combination products of medicine and machinery, so as to avoid making the big picture and table hard to see because of small projects B This statistics does not include supplementary application, re registration and re examination, which will directly affect the results if mixed in C The review conclusion does not include the non terminal situation such as issuance and supplement 3、 The registration personnel of Tianfang pharmaceutical industry is undoubtedly the most diligent model worker On average, they should apply for at least one registration application in one day Someone asked, did not see his home has so many acceptance number ah, pro, I here include all acceptance number, into the CDE acceptance number is just the tip of the iceberg 2 Small reminder of the list of the most innovative awards and class 1 new drug application: the statistical caliber here is drugs, and the number of multi dosage forms and multi specifications is counted as a single drug.