2014 China drug review report

1 Chemical drugs 1 Application acceptance: the number of chemical drug applications has increased year by year, with the increase mainly concentrated in new drugs and import re registration In 2014, the number of new chemical drug applications undertaken by CDE totaled 7807, a new record Compared with the same period last year (6411), the growth rate is about 22%, and the detailed data of each application type is shown below As can be seen from the above figure, the application volume of import and supplement is not big compared with that of previous years; the application volume of generic drugs is increasing year by year, but the increase is not big compared with that of 2013 in 2014; while the application volume of new drugs and import re registration is greatly increased, and the application volume of import re registration in 2014 even more than doubled compared with that in 2013 Last year's drug shortage in more than 100 countries also made pharmaceutical companies pay attention to drug re registration (1) the number of new drug applications has increased significantly According to the statistics of insight database of DXY, in 2014, the number of new chemical drug applications undertaken by CDE reached 2321, the highest in five consecutive years Compared with the same period last year, the growth rate is up to 46% As can be seen from the figure above, the application volume of new chemical drugs is increasing year by year, and the application volume of the last two years is also increasing compared with the same period of previous years Among them, the same is true for class 1.1 and class 3.1 new drugs In recent years, the state has encouraged innovation, set up special review and approval channels for some innovative drugs and drugs in urgent clinical need, and inclined the review resources to innovative drugs It is also the key to improve the R & D capability of pharmaceutical enterprises Cooperation with universities and other scientific research institutions and foreign drug R & D institutions is common ① In 2014, 61 new drugs of category 1.1 were applied for clinical application According to the statistics of insight database of DXY, in 2014, CDE undertook 155 new applications of chemical drugs of category 1.1, involving 64 varieties, with the majority of anti-tumor drugs This is an increase compared with 53 varieties in 2013 Among them, 61 varieties have applied for clinical application and 3 varieties have applied for listing (benzcycloquinium bromide of Yingu pharmaceutical, p-toluenesulfonamide injection of anti-tumor drug of Tianjin HongRi pharmaceutical and etakalin of Enhua pharmaceutical) Jiangsu Hengrui has 4 varieties applied for clinical application (shr3680, shr4640, shr6390, shr7390), ranking first in quantity Guangdong dongyangguang (imitavir, lelotinib, boxitinib) and Zhaoke Pharmaceutical (Shengfa peptide, thymosin, and celeprasidine) have three varieties applied for clinical application respectively, and they are tied for the second place It is worth noting that among the 61 new drug varieties of 1.1 category newly applied for clinical application, 7 of them have been listed as major special varieties, and the detailed data are as follows Among them, the anti-tumor drugs of Hangzhou Huadong pharmaceutical, mehuatinib, and the anti hepatitis C drugs of dongyangguang, imitavir, were approved for clinical use in 2014 ② 3.1 new drug class 3.1 application volume has increased significantly In 2014, CDE co sponsored 1619 new drug class 3.1 applications with acceptance number, up 58% compared with 1025 applications in 2013 Now the information is more and more open, some drugs are on the market in foreign countries, and domestic manufacturers have begun to declare and rush to do the first imitation soon For example, Geely's star hepatitis C drug sofosbuvir (trade name: sovaldi, Chinese Name: sofibvir, sofobvir), was first approved by the US FDA in December 2013 In the past three months in China, only from October to December, six enterprises (Beijing Kawei, Kelun, Shiyao, Zhengda Tianqing, Beijing Wansheng and hausen) have submitted their applications for class 3.1 new drugs However, sofosbuvir's clinical application for imported new drugs was submitted in August 2013 and approved in December 2014 (2) The number of generic drug applications is increasing year by year, and the phenomenon of low-level repeated applications is still serious In 2014, the number of applications for generic drugs jointly undertaken by CDE reached 2117, a slight increase compared with 2013 Generally speaking, in the past five years, the application volume of generic drugs has been increasing year by year, and there are some over repeated varieties that have been declared continuously At present, the current situation of generic drugs is that on the one hand, CDE has a backlog of historical tasks, and generic drug evaluation has a long waiting time; on the other hand, enterprises have excessively low level of repeated declaration, which is increasing the burden of CDE and wasting limited evaluation resources In July 2014, CDE published the electronic publication "several key issues in generic drug research and development", emphasizing the basic ideas and quality requirements of generic drug research and development; in September and November, CFDA screened and published two batches of excessively repetitive drug varieties catalogue according to the number of drug approval numbers and registration applications, in order to guide enterprises to apply rationally (3) In 2014, CDE undertook 573 new applications for import of chemical drugs with acceptance number, which was less than that in previous years 2 The historical task backlog of review queuing time is serious, and the queuing time of most review channels continues to extend As can be seen from the figure above, the review waiting time of ind, confirmatory clinical, NDA and anda review sequences has continued to extend in recent years, and the queuing time of only supplementary applications and import re registration sequences has remained relatively stable Among them, the queuing time of ind, confirmatory clinical and NDA sequences increased by more than 30% in 2014 compared with 2013 This shows that the backlog of historical tasks is still quite serious CDE, which has been criticized for its slow review, has conducted three public recruitment in 2014, and the number of announced candidates has reached 20, the total number of recruitment in recent years It remains to be seen whether the efficiency of CDE evaluation can be significantly improved Note: clinical trial application for new drugs (ind): including registration classification 1, registration classification 2 and international multi center clinical trial application; confirmatory clinical: clinical trial application for registration classification 3 and 4; new drug production and marketing application (NDA): production and marketing application after clinical trial; Anda: application for bioequivalence test and production listing for registration classification 5 and 6; supplementary application and import re registration application are the same as the description of drug registration classification; import registration application is classified above according to the actual application type 3 The number of approved chemical drugs has decreased year by year in the past five years According to the statistics of insight database of DXY, for the registration application of chemical drugs, in 2014, CFDA approved 3731 approved chemical drugs, a slight decrease compared with 2013 But on the whole, the number of approvals has continued to decline in the past five years Next, let's take a look at the approval of clinical and marketing of chemicals (1) The number of clinical approval documents of approved clinical drugs has increased, mainly concentrated in the statistics of new drugs according to insight database In 2014, a total of 703 clinical approval documents of chemical drugs were approved, an increase of nearly 11% compared with 632 approved in 2013 The trend of clinical approval of each application type is as follows: From the above figure, we can see that the clinical data of new drug approval increased by 50% compared with 2013; the number of clinical approval documents of generic drugs decreased by 46% compared with 2013; the number of clinical approval of other application types was relatively stable Compared with the previous years, the number of approved class 1.1 new drugs and the review time in 2014 have little change According to the insight database statistics, there are 29 varieties of class 1.1 new drugs approved in 2014, almost the same as the 30 varieties approved in 2013 The majority of these varieties are still antineoplastic drugs In 2014, two 1.1 varieties of the following enterprises were approved for clinical use: Jiangsu Hengrui (furgliefan, midji), Jiangsu Haosen (flumateni, hs-10182, note: flumateni was originally applied for listing but still needs clinical trials), Jiangsu Yasheng (apg-1387, R - (-) - gossypol acetate), Zhejiang Haizheng (HPPH, hebofeiming) In addition, in terms of review time, except for a few varieties declared in 2012 and before, the vast majority of them are varieties declared in 2013 From declaration to approval, most of them took about one year, with little fluctuation compared with previous years Among them, there are two varieties that have been approved since 2014, which are all major special projects: the anti-tumor drug of Hangzhou Huadong pharmaceutical, mehuatinib, and the anti hepatitis C drug of dongyangguang, imitavir Mehuatinib was declared in March 2014, and was approved in October 2014 It lasted only 7 months, the shortest time among these varieties (2) According to the statistics of insight database, in 2014, CFDA approved 421 chemical drug listing applications (calculated by acceptance number, not included in the number of approved import re registration and approved supplement), which decreased by 15% compared with that in 2013 (483) In general, the number of chemical drugs approved for marketing in the past five years is decreasing year by year, and mainly concentrated on generic drugs In recent years, the food and drug administration has strengthened the evaluation requirements and quality control of domestic generic drugs According to the statistics of insight database, in 2014, 3 new chemical drugs of category 1.1 were approved for listing, which is the same as that of 2013 They are apatinib (API and tablet) which is a heavy-duty gastric cancer targeting drug of Jiangsu Hengrui, moroxynidazole (API and injection), adefovir dipivoxil (API) of Hunan Fangsheng and Hunan Warner, and adefovir dipivoxil tablets of Suzhou Erye According to the statistics of insight database, the first domestic generic drugs approved for marketing in 2014 were sofacone (API and dry suspension) and Haosen agomeladine (API and tablet) of Wuhan Qirui According to the statistics of insight database, there were 57 applications for approval of chemical drug import listing in 2014 with acceptance number, involving 31 varieties, a decrease compared with the same period of previous years Among them, there are five varieties that have been approved for the first time in China: gadolinitol injection, laboratorios pharmaceuticos Rovi, a contrast agent for MRI of Bracco, S A the company's antithrombotic drug bemiheparin sodium injection, the antithyroid drug sinakase hydrochloride tablets of kylin Co., Ltd., the travotimo eye drops of Erkang, and the antithrombotic drug nadroparin calcium injection of GlaxoSmithKline are the first approved imported drugs in China 2、 Application and acceptance of traditional Chinese medicine: the application volume of traditional Chinese medicine has decreased year by year According to the statistics of insight database of DXY, in 2014, the number of new applications for registration of traditional Chinese medicine undertaken by CDE is 531, which is the lowest point in the past five years It can be seen from the data that in recent years, the application volume of traditional Chinese medicine has been decreasing year by year Among them, there are three kinds of new drugs of class 1 The five hydroxyflavones and suanshuaan capsules of the Institute of traditional Chinese medicine of the Chinese Academy of Chinese medicine are applied for clinical application, and the astragaloside A and astragaloside A and glucose injection of Guizhou Jingfeng injection Co., Ltd are applied for listing However, the five hydroxyflavones and suanshuaan capsules from the Institute of traditional Chinese medicine, Chinese Academy of traditional Chinese medicine have been concluded and not approved Examination and approval: compared with 2013, the number slightly increased In 2014, the number of approved clinical and approval of traditional Chinese medicine was slightly increased