Analysis report on drug registration of Jiangsu Province in 2015

[Abstract] Jiangsu Province has a strong momentum in drug research and development, and the number of drug registration applications has been ranked first in China for years This paper focuses on the analysis of drug registration in Jiangsu Province in 2015 and the 12th Five Year Plan period, and puts forward measures to further improve the drug registration management in Jiangsu Province 2015 is the final year of completing the 12th Five Year Plan in an all-round way, and also the crucial year of deepening the reform of drug review and approval mechanism in an all-round way The author summarized and analyzed the acceptance, approval and management of drug registration in Jiangsu Province in 2015 and the 12th Five Year Plan period (2011-2015), providing relevant reference for the R & D and management personnel of pharmaceutical enterprises 1 Acceptance and analysis of drug registration applications 1.1 acceptance overview and analysis In 2015, Jiangsu Province accepted 790 drug registration applications submitted to the State Food and Drug Administration (hereinafter referred to as the State Administration), down from the previous year During the 12th Five Year Plan period, Jiangsu Province accepted 3608 drug registration applications, including 3430 chemical applications, accounting for more than 95% of the total number of the province; the application volume of traditional Chinese medicine remained stable; the application volume of biological products increased significantly in recent three years (see Figure 1) During the "12th Five Year Plan" period, Jiangsu Province has a strong momentum in drug research and development, with the application volume of new drugs exceeding that of generic drugs (see Figure 2), outstanding research and development capacity of innovative drugs, and the application volume leading the whole country 1.2 chemical drug registration acceptance and analysis: in 2015, Jiangsu Province accepted 760 chemical drug registration applications, accounting for 15% of the total number of applications (5138), including 524 new drug confirmatory clinical research applications, accounting for 23% of the total number of applications (2296) (see Figure 3) It can be seen from the data that in recent years, the focus of new drug development of drug research and development units in our province is relatively concentrated, most of which are strong imitations of foreign listed varieties In terms of the declared varieties, in 2015, the number of chemical drug list varieties in Jiangsu Province reached 10 More than enterprises: alprost, sacarbutrovalastan sodium, tragliptin succinate, posaconazole, ezemeb, avanafil, quetiapine fumarate, lovatinib mesylate, carbotinib malate, wotixitin hydrobromide, terdazolamine phosphate and tadalafil, all of which are chemical drugs 3 The main indications of new drugs are endocrine system diseases, anti infection, cardiovascular diseases and anti-tumor According to the 2015 China drug review report released by the drug review center of the State Administration of drugs, there are more than 50 tasks to be reviewed in the above varieties, such as alprost, tragliptine and avaanafil, with serious repeated applications From the perspective of declaration subject, the top 10 enterprises in the declaration volume of chemical drug list varieties in Jiangsu Province in 2015 are mainly drug production enterprises, with the cumulative declaration volume accounting for 73.2% of the total (see Table 1) Table 1 the top 10 enterprises (based on the acceptance number) in the declaration volume of chemical drug list varieties in Jiangsu Province in 2015 ranked the number of enterprise name declaration pieces 1 Zhengda Tianqing Pharmaceutical Co., Ltd 91 2 Nanjing Huawei Pharmaceutical Technology Co., Ltd 70 3 Jiangsu aosaikang pharmaceutical 40 4 Jiangsu Haosen pharmaceutical Nanjing Xiansheng Dongyuan pharmaceutical 34 34 5 Jiangsu Hengrui pharmaceutical 26 6 Nanjing Zhengda Tianqing pharmaceutical 25 7 Nanjing Haina Pharmaceutical Co., Ltd 24.8 Jiangsu Wanbang Pharmaceutical Co., Ltd 21.9 Jiangsu Xiansheng Pharmaceutical Co., Ltd 19 10 Jichuan pharmaceutical 16 from the perspective of regional distribution, 2015 In, the main bodies of drug registration and application in Jiangsu Province were mainly concentrated in Nanjing, Lianyungang, Taizhou and Suzhou (see Figure 4) 1.3 acceptance of innovative drug registration and analysis: in 2015, Jiangsu Province accepted 68 applications for registration of innovative drugs (referring to chemical drugs 1, 2, traditional Chinese medicine 1-6, biological products 1-14), including 42 chemical drugs, 7 traditional Chinese medicine, and 19 biological products There are 33 applications for the registration of innovative chemical drugs in Category 1, mainly for clinical research, mainly in the fields of tumor, endocrine, hepatitis and other treatment; only one variety (3 acceptance numbers) has applied for production registration, which is retagliptin phosphate and its tablets, used for diabetes treatment During the "12th Five Year Plan" period, Jiangsu Province accepted 217 new drugs of class I (refer to chemical medicine class 1, traditional Chinese medicine class 1, biological products class 1), including 195 clinical research applications and 22 production registration applications (see Figure 5) From the perspective of the application area, the R & D units of class I new drugs are mainly concentrated in Lianyungang, Nanjing, Taizhou (Taizhou pharmaceutical city) and Suzhou (Suzhou Industrial Park) 2 Drug registration application approval and analysis 2.1 analysis of approval in 2015: in 2015, Jiangsu Province received a total of 1105 drug approvals from the State Administration, including 682 approvals, with the approval rate of 62%, down 22 percentage points from the previous year Among the approval documents, there are 477 drug registration approval documents, with the approval rate of 58% (see Table 2); 205 drug supplementary application approval documents, with the approval rate of 74% Table 2 drug registration and approval in Jiangsu Province in 2015 approved new drugs (including drugs according to new drug management) with total national standards 6-9 in 1-3, 1-14 in 5 Hua6sheng 15 clinical study / piece 40 249 15 5 11 124 1 445 production registration / piece 0 7 0 4.021.032 compared with the data of announcement No.39 of the State Administration in 2016, there were 32 drugs with production approval number in Jiangsu Province in 2015 In 2015, there were 445 varieties of drugs approved for clinical research in Jiangsu Province, accounting for 9.7% of the total number of drugs approved for clinical research in China (4573), of which 44 innovative drugs were approved for clinical research, reaching a new high in batches 2.2 analysis of approval during the 12th Five Year Plan period the whole province actively responded to the call of the State Administration for drug review and approval reform during the 12th Five Year Plan period, attached great importance to the acceptance and verification of drug registration, and constantly improved the quality of registration and application The approval rate increased from 2011 to 2014, 2015 The annual approval rate is 22% lower than that of the previous year (see Table 3), which is mainly affected by the policies of the State Administration of the people's Republic of China, such as adjusting the registration fee standard, improving the requirements for acceptance, review and evaluation, and carrying out the self-examination and verification of drug clinical trial data A large number of varieties have been withdrawn by enterprises to be re studied In terms of the number of approved varieties, the new drug R & D achievements of Jiangsu Province during the 12th Five Year Plan period are quite outstanding (see Figure 6) During the 12th Five Year Plan period, the number of drugs approved for clinical research in Jiangsu Province increased significantly, reaching 445 in 2015 (see Figure 7) Table 3 approval rate of Jiangsu Province in the year of drug registration and approval during the 12th Five Year Plan National average approval rate /% chemical and traditional Chinese Medicine Biological Products 2011 124 13 1 203 68 73 2012 149 6 4 206 77 74 2013 149 6 4 211 75 71 2014 175 1 4 224 80 66