The number of drug declarations has reached a new high!

In recent years, domestic drug registration is still in a state of vigorous development, and the number of CDE acceptance numbers has increased significantly; as of December 31, 2021, the CDE Evaluation Center has accepted a total of 11,569 acceptance numbers (data statistics as of December 31, 2021.

Application of each drug type

In terms of the total number of acceptance numbers, from 3,779 applications in 2016 (in terms of acceptance numbers) to 11,569 in 2021, the number has been increasing year by year; among them, 8,174 applications for chemical drugs will be accepted in 2021, which is not much different from 7,907 in 202 , 2022 biological drugs, only 154 different from 1868 in 2020, and there is not much difference, but the application of traditional Chinese medicine in 2021 is significantly higher than the 472 in 2020, reaching 1371, reaching the peak of the number of traditional Chinese medicine declarations in the past 6 year.

Figure 1 Data source of application details in 2021: Yaozhi Data

Figure 2 Comparison of application acceptance in 2021 and 2020 Data source: Yaozhi data

Application area

In terms of drug declarations in various provinces and cities, the annual declarations in 2021 are the same as in the first half of 202 Jiangsu is far ahead with 1750, followed by Shanghai with 1307, followed by Beijing, Guangdong and Zhejian.

Figure 3 Distribution of declarations by provinces in 2021 Data source: Yaozhi data

General situation of various types of declarations

The proportion of application types in the whole year of 2021 is basically the same as that in the first half of 202 It is still dominated by supplementary applications, accounting for 6,089 of the entire application type.

Figure 4 Source of classification data for application acceptance in 2020: Yaozhi Data

Figure 5 Source of classification data for application acceptance in 2021: Yaozhi Data

Note: Statistical rules: S, L, B, Z are the 4th letter of the acceptance number respectively

Application and completion of review in 2021

According to the latest statistics of Yaozhi’s registration and acceptance database, the number of acceptance numbers that have completed the review in 2021 (Note: CDE’s undertaking date is from January 1, 2021 to December 31, 2021) (referring to the review conclusions included in Yaozh.

Figure 6 Data source of CDE’s hosting and approval in 2021: Yaozhi Data

Completion of the review in 2021

According to the latest statistics of the Yaozhi registration and acceptance database, in 2021 (note: the status start time (Yaozhi) is from January 1, 2021 to December 31, 2021) the number of acceptance numbers that have been reviewed and completed will be 11,210, which will be included in Yaozh.

Figure 7 Details of the CDE review conclusion in 2021 Data source: Yaozhi Data