Analysis report on drug review in Chongqing in 2014 -- from the database of drug intelligence registration and acceptance

Guide: with the rapid development of Chongqing's economy in recent years, what will be the development of Chongqing's pharmaceutical industry this year, especially in the field of drug declaration? According to the latest statistics of drug intelligence registration and acceptance database, in 2014, CDE undertook 180 new drug registration applications in Chongqing with acceptance number (excluding reexamination, the same below), accounting for 2% of the total acceptance of the whole country Figure 1: the trend chart of drug acceptance in Chongqing from 2011 to 2014 was in full swing in 2014 when the national drug registration declaration was in full swing However, the number of drug acceptance in Chongqing has been declining since it reached its peak in 2012, with a decrease of nearly 36% compared with 2012 Next, let's analyze the registration acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products Figure 2 drug acceptance in Chongqing from 2011 to 2014 167 chemical drugs (calculated by acceptance number, the same below), 10 traditional Chinese medicines and 3 biological products were accepted in 2014 The acceptance of chemical drugs also continued to decline after 2012, a decrease of 34.5% compared with 2012 1、 In 2014, a total of 47 new chemical drugs, 80 generic drugs and 40 supplementary applications were accepted Figure 3 acceptance of chemical drugs in Chongqing from 2011 to 2014 As mentioned above, the acceptance of chemical drugs continued to decline after 2012 As can be seen from the figure above, it is mainly reflected in the decrease of supplementary applications The decrease of supplementary applications in 2013 and 2014 is particularly significant compared with that in 2011 and 2012 (it can only be said that the original is almost finished) In 2014, the acceptance of generic drugs decreased compared with 2013 In terms of new drug acceptance, the number of new drug acceptance in 2014 was basically the same as that in 2013, with a slight decrease, but the proportion of new drug application increased To some extent, this series of data also reflects the improvement of the quality of chemical application Enterprises may focus more on the research and development of new drugs The following is a detailed analysis of Chongqing Chemical acceptance in 2014 1 The number of new chemical drugs declared in 2014 was 47, accounting for 28.1% of the total 85.1% of them are new drugs of category 3.1, an increase of 29% compared with 2014; the number of new drugs of category 1.1 is 0, while in 2013, 8 new drugs of category 1.1 were accepted, involving 3 varieties (if you want to know the specific situation, please pay attention to the database of drug intelligence registration and acceptance) With regard to the acceptance of new drugs in Chongqing from 2011 to 2014, the pharmaceutical enterprises in Chongqing have maintained a good development momentum in the research and development of class 3.1 new drugs, but there is still a very big gap between the original new drugs and some pharmaceutical provinces, or the research and development bull enterprises like Hengrui 1) In 2014, there were 40 new drugs in 3.1 category accepted by CDE Involving 16 enterprises and 30 varieties As a whole, from 2011 to 2014, the number of chemicals accepted by 3.1 is on the rise, especially the application of APIs, which totaled 31 in 2014, involving 28 varieties Figure 4: statistical rules of 2014 Chongqing Chemical Medicine 3.1 new drug acceptance ranking: 1 Statistics of APIs and preparations respectively; 2 Statistics of the same preparation of the same manufacturer with different specifications, calculated as one item, i.e statistics only once; 3 Statistics of products of the head office and subsidiaries respectively; 4 Statistics of different preparation types respectively 2) Others are attached with the acceptance of new chemical drugs in Chongqing in 2014 2 The number of new chemical drug applications for generic drugs in 2014 was 80, with a total of 22 application enterprises Figure 5 statistical rules of Chongqing Chemical and generic drug acceptance ranking in 2014: 1 Statistics of APIs and preparations respectively; 2 Statistics of the same preparation of the same manufacturer with different specifications, calculated as one item, i.e statistics only once; 3 Statistics of products of the head office and subsidiaries respectively; 4 Statistics of different preparation types respectively 2、 In 2014, CDE undertook 10 new applications for registration of traditional Chinese medicine with acceptance number Figure 6 acceptance of CDE traditional Chinese medicine in January 2015 CDE only undertook one acceptance of new traditional Chinese medicine in 2014: the 6 categories of new traditional Chinese medicine drugs - chingtai ointment, which was declared by the old traditional Chinese medicine factory Taiji Group Chongqing TongJunGe Pharmaceutical Co., Ltd at the end of 2013, was accepted by CDE in August 2014 The rest are supplementary applications 3、 In 2014, two class 1 biological products were accepted in Chongqing Note: in the statistical process, the data may be missing Forgive Zifu's ignorance and lack of knowledge about the names of all pharmaceutical enterprises in Chongqing This statistics includes 38 pharmaceutical enterprises in Chongqing The above data comes from the registration and acceptance database of pharmaceutical intelligence