2019 CDE annual drug review report: 589 chemical class 1 applications 1045 anda

According to the latest statistics of drug intelligence data, in 2019, CDE undertook 8056 new drug registration applications with acceptance number (excluding reexamination, the same below) Influenced by clinical verification, consistency evaluation and new policies related to drug registration, the number of drugs dropped significantly in 2016 and 2017, and the total number of drugs accepted decreased significantly In 2018, the total amount of acceptance basically returned to normal In 2019, the total amount of acceptance began to rise, including 6459 chemical drugs, 416 traditional Chinese medicines and 1158 biological products (Figure 1) Figure 1 acceptance of CDE drugs in 2011-2019 Compared with 2018, the number of drug declarations in the same period in 2019 fluctuated slightly, with a peak of 905 in January (Figure 2) Figure 2 monthly acceptance of CDE drugs in 2019 In 2018, due to the impact of the consistency evaluation cut-off point, the number of supplementary applications increased significantly (Figure 3), and 2019 supplementary applications reached a new height, accounting for 54.12% of the total accepted in 2019 Note: statistical rules: s, l, B and Z are the 4th letter of acceptance number respectively Figure 3 acceptance of CDE drug application types in 2018-2019 In terms of drug declaration in various provinces and cities, Jiangsu still leads with 930 acceptance numbers, followed by Shanghai, Beijing, Guangdong and Zhejiang (Figure 4) Figure 4 declaration of provinces and cities in 2019 Let's analyze the acceptance and evaluation of registration of chemical drugs, traditional Chinese medicine and biological products 1 Chemical application in 2019 In 2019, CDE undertook 6459 new chemical registration applications with acceptance number From the downturn in 2016 and 2017, chemical declaration gradually returned to normal in 2018 and began to rise in 2019 (Figure 5), reaching a peak of 772 in January Figure 5 acceptance of CDE chemicals every month in 2019 Among the chemicals declared in 2019, there are 1045 anda applications, 695 ind applications, 130 NDA applications and 1692 supplementary applications See the figure below for details (Figure 6) Figure 6 acceptance of chemical tasks in 2019 In the field of chemical medicine, due to the continuous impact of the cut-off point of consistency evaluation (consistency evaluation varieties are applied for registration and declaration according to the supplementary application in the registration classification item), the proportion of supplementary application and registration of chemical medicine in this year accounts for 59% of the total amount of chemical medicine declaration (Figure 7) Figure 7 acceptance of application types of CDE chemicals in 2019 According to the current registration classification of chemical drugs, chemical drugs category 1 is defined as: innovative drugs that are not listed at home and abroad, including APIs and their preparations that contain new compounds with clear structure and pharmacological effects and have clinical value In 2019, 589 new chemical drugs of category 1 were declared Figure 8 acceptance of CDE class 1 new drugs every month in 2019 The number of applications for each task type of chemical category 1 is ind552, nda21, 12 supplementary applications (clinical) and 4 supplementary applications (Pharmacy) (Fig 9) Figure 9 application quantity of chemical medicine category 1 task types in 2019 In 2018, a total of 541 applications for import registration of chemical drugs, including the application for import and the application for clinical varieties, were undertaken Figure 10 acceptance of CDE imported chemicals every month in 2019 Influenced by the cut-off points of consistency evaluation, the peak number of consistency evaluation is 207 in January Figure 11 acceptance of monthly CDE conformance assessment in 2019 According to the latest statistics of drug intelligence registration and acceptance database, in 2019 (Note: the start date of status is from January 1, 2019 to December 31, 2019), there are 2453 acceptance numbers (referring to the number of varieties that CDE has completed the technical review and transferred for approval, and the processing status includes the status of approval, pending approval, approval or certification completion, in terms of acceptance numbers), including 1810 chemical drugs , 261 traditional Chinese medicine, 370 biological products (Figure 12) Figure 12 review results of drug types of CDE in 2019 In terms of chemical drug review, according to the latest statistics of drug intelligence data, the number of chemical drugs completed in this year is up to 1285 acceptance numbers of supplementary applications, followed by other 337 (Figure 13) Figure 13 review of CDE chemicals in 2019 In 2019, the most approved application is supplementary application, followed by import approval For specific conclusions, please refer to the drug registration and acceptance database of yaozhi.com (FIG 14) Note: the statistical time is January 3, 2020 Statistics at different time points will cause differences in the number of completed audits and the number of review conclusions Figure 14 chemical review conclusion in 2019 In 2019, CDE undertook 416 new applications for registration of traditional Chinese medicine with acceptance number, down 2.35% from 426 in 2018 (FIG 15) Figure 15 acceptance of CDE traditional Chinese medicine every month in 2019 Generally speaking, the application of traditional Chinese medicine has been in a relatively low state, with fewer new drug applications The acceptance number is mainly concentrated in supplementary applications, and how to change is also worth thinking in the industry In 2018, CDE undertook 1158 new biological product registration applications with acceptance number, an increase of 25.46% compared with 923 in 2018 Figure 16 monthly acceptance of CDE biological products in 2019 In this year, 127 biological products for class 1 treatment were declared (Table 1) Table 1 class 1 biological products for treatment declared in 2019