Analysis report of CDE drug acceptance in 2015 - drug intelligence registration and acceptance database

According to the latest statistics of drug intelligence database (from January 1, 2015 to December 31, 2015), there were 8115 new drug registration applications accepted by CDE in 2015 (excluding reexamination, the same below), including 7085 chemical drugs, 361 traditional Chinese medicine and 552 biological products The comparison with the various drug types undertaken in previous years is shown in Figure 1 Figure 1 The acceptance of various drug types of CDE in 2011-2015 was a "turbulent" year in the pharmaceutical industry At the end of May 2015, the new version of drug and medical device product registration fee standard was announced With the development of clinical self-examination in July and the successive release of relevant announcements, the number of CDE acceptance decreased in August, just 575 acceptance numbers Since August, the number of monthly acceptance is lower than that of the same period last year (see Figure 2) Figure 2: the acceptance status of each drug type of CDE in 2015, while the acceptance number of clinical application in this year is increasing continuously, accounting for 38% (see Figure 3), up 18.5% compared with 2014, especially in confirmatory clinical, which has a certain relationship with the rapid growth of 3.1 new drugs Note: statistical rules: s, l, B and Z are the 4th letter of acceptance number respectively Figure 3: Analysis on the registration, acceptance and review of chemical drugs, traditional Chinese medicine and biological products under the types of drug applications undertaken by CDE in 2015 1、 Acceptance of chemical drugs in 2015, CDE undertook 7085 new chemical registration applications with acceptance number, accounting for 87.3% of the total number of applications accepted In August 2015, the number of chemical drugs accepted also decreased significantly In the last quarter, the General Administration of drug administration started the on-site verification of clinical trial data Affected by this, the number of acceptances did not exceed 500 Figure 4 The acceptance of CDE chemicals every month in 2015 In 2015, major pharmaceutical enterprises were severely hit But it is gratifying that the application of new chemical drugs seems to usher in a spring The number of application acceptance reached 2704 (see Figure 5), surpassing the application of generic drugs for the first time, accounting for 38% of the acceptance of chemical drugs This is indeed a milestone for China's pharmaceutical research and development Figure 5 acceptance of CDE chemical drugs in 2015, among which chemical drugs category 3.1 is still the leader with 1900 applications, while chemical drugs category 6 (i.e generic drugs) have 1893 applications In 2015, a total of 199 acceptance numbers were applied for chemical 1.1 new drugs, involving 74 varieties and 68 application enterprises Figure 6 acceptance of various registration types of CDE chemicals in 2015 On August 8, 2015, the State Food and Drug Administration issued the announcement of opinions on the evaluation of the consistency of quality and efficacy of generic drugs (Draft for comments) (No 231, 2015), which had a great impact on the application of generic drugs, some people even called it "devastating" It is assumed that in a long period of time, the application of generic drugs will continue to decline However, the norms of generic drugs are of great significance to China's transformation from a low-level generic country to an innovative or high-level generic country Will 2015 be a key turning point, and the pharmaceutical intelligence data will continue to focus on it 2、 Acceptance of traditional Chinese medicine in 2015, CDE undertook 361 new applications for registration of traditional Chinese medicine Figure 7: Overall, the application status of traditional Chinese medicine in CDE in 2015 is not optimistic, especially the application of new drugs According to the statistics of drug intelligence data, in 2015, there were 81 acceptance numbers of new traditional Chinese medicine, mainly concentrated in 6 categories of traditional Chinese medicine, and 3 enterprises applied for class 1 new Chinese medicine (see Table 1), table 1 Class 1 new Chinese medicine in 2015 The large investment, long cycle, low passing rate and high risk of new Chinese medicine R & D in China make many enterprises and scientific research institutions hold back the R & D of new Chinese medicine, and the proportion of new Chinese medicine in the evaluation process is decreasing year by year In 2015, Tu youyou won the Nobel Prize, which is a face for traditional Chinese medicine We haven't talked about "the dispute between Chinese and Western medicine" much here We just hope that through this event, more people around the world will pay attention to traditional Chinese medicine, so that it can develop healthily and pass on 3、 Acceptance of biological products in 2015, CDE undertook 552 new biological product registration application acceptance numbers Figure 8: acceptance of CDE biological products in 2015: biomedicine is the key field of global new drug research and development, such as the application of genetic engineering drugs, gene therapy, drug genome, etc., which is closer to the concept of precision medicine than traditional chemical drugs But the domestic start is relatively late, and we really need to work hard to catch up with foreign cutting-edge technologies Data source: drug intelligence registration and acceptance database note: the intellectual property rights of the above articles are owned by drug intelligence If you need to reprint, please indicate the source and the link of this article.