2019 CDE annual drug review report: 589 chemical class 1 applications, 1045 anda, 695 ind, 130 NDA

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: compared with 2018, the number of drugs declared in the same period of 2019 fluctuated slightly, with a peak of 905 in January (Figure 2) Figure 2 The acceptance of CDE drugs in each month in 2019 in 2018, due to the impact of the consistency evaluation cutoff 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 acceptance in 2019 Note: statistical rules: s, l, B and Z are the 4th letter of acceptance number respectively Figure 3 in the acceptance of CDE drug application types in 2018-2019, Jiangsu still leads in 930 acceptance numbers of drug applications in various provinces and cities, followed by Shanghai, Beijing, Guangdong and Zhejiang (Figure 4) Figure 4 The application of provinces and cities in 2019 Let's analyze the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products 1、 Chemical 1 Chemical application in 2019 CDE undertook 6459 new chemical registration applications with acceptance number in 2019 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 monthly in 2019 among 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) Fig 6 acceptance of each task type of chemical drugs in 2019 from the perspective of chemical drugs field, due to the continuous influence of consistency evaluation cutoff (consistency evaluation varieties are applied for registration and declaration according to supplementary application in the registration classification item), the proportion of chemical drugs supplementary application and registration and declaration in this year accounts for 59% of the total chemical drugs declaration (Fig 7) Figure 7 acceptance of application types of CDE chemical drugs in 2019 ◆ 1.1 application of new chemical drugs of category 1 is classified according to current chemical drug registration Chemical drugs of category 1 are 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 The number of applications for each task type of chemical drug type 1 for CDE chemical drug type 1 in 2019 is ind552, nda21, 12 supplementary applications (clinical) and 4 supplementary applications (Pharmacy) (Fig 9) Fig 9 application quantity of each task type of chemical drug category 1 in 2019 ◆ 1.2 declaration of imported chemical drugs in 2018, there are 541 chemical drug import registration applications with acceptance number, including declaration of import and declaration of clinical varieties Figure 10 acceptance of CDE imported chemicals every month in 2019 Figure 11 acceptance of monthly CDE consistency assessment in 2019 2 Completion of chemical drug review 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: in the chemical drug review of CDE in 2019, according to the latest statistics of drug intelligence data, the maximum number of chemical drugs completed in this year is 1285 acceptance numbers of supplementary applications, followed by other 337 (Figure 13) Figure 13 review and conclusion of CDE chemicals in 2019 the most approved is supplementary application in 2019, followed by import approval Please refer to drug registration and acceptance database of yaozhi.com for specific conclusions (Figure 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 review conclusion of chemical drugs in 2019 II In 2019, there are 416 new applications for registration of traditional Chinese medicine undertaken by CDE of traditional Chinese medicine with acceptance number, down 2.35% compared with 426 in 2018 (FIG 15) FIG 15 in 2019, in general, the application of traditional Chinese medicine has been in a relatively low state, with few new drug applications The acceptance number is mainly focused on supplementary applications, and how to change is also worth thinking in the industry 3、 In 2018, CDE undertook 1158 new applications for registration of biological products with acceptance number, an increase of 25.46% compared with 923 in 2018 Figure 16 acceptance of CDE biological products monthly in 2019 this year, a total of 127 biological products for class 1 treatment were declared (Table 1) Table 12019 data source of class 1 biological products for treatment declared in 2015: the statement of hearing from the registration and acceptance database of Zhiyao: this opinion only represents the author, not the position of Zhiyao Welcome to exchange and supplement in the message area; if you need to reprint, please make sure to indicate the author and source of the article.