The number of medicines declaration reached a new high!The number of declarations in these areas is the largest ...

Source: Yaozhi.com/Seventeen

In recent years, domestic drug registration is still in a vigorous development state, and the number of CDE has increased significantly. As of December 31, 2021, the CDE review center has accepted a total of 11,569 acceptance numbers (data statistics as of December 31, 2021, 2021, 2021 31, 2021 On the same day, the same), the number of clinical and production is significantly improved compared to 2020. Among them, there are 2452 acceptance numbers who have declared clinical clinicals, and 2157 acceptance numbers are declared. The following is a detailed analysis of the acceptance of 2021:

1. Declaration of various medicines

Regarding the total number of acceptance numbers, the number of applications from 3,779 (with the acceptance number) in 2016 to 11,569 in 2021, the number has risen year by year; of which 8,174 applied for the application number of chemical drugs in 2021, which is not much different from the 7907 in 2020 in 2020. , 222 biopharmaceuticals, only 154 differences from 1868 in 2020, are also not much different, but the application of Chinese medicine in 2021 has increased significantly compared with 472 in 2020, which is 1371, reaching the peak of the number of Chinese medicine declarations in the past 6 years, and the number of Chinese medicine declarations in the past 6 years. Essence

Figure 1 Declaration details in 2021

Data source: medicine wisdom data

Figure 2 The comparison of the application for acceptance in 2021 and the comparison of 2020

Data source: medicine wisdom data

2. Application area situation

In terms of drug declarations in various provinces and cities, the application of 2021 was consistent with the first half of 2021. Jiangsu led 1750 with 1750. Secondly, Shanghai ranked second with 1307, and then in order to be Beijing, Guangdong, and Zhejiang. In addition, the number of drug declarations (31 items) in Taiwan's Taiwan Province is higher than that of Ningxia, Tibet and other provinces. The declaration of the provinces and cities in 2021 is shown in Figure 3.

Figure 3 The distribution of declarations of each province in 2021

Data source: medicine wisdom data

3. The overall situation of various types

The proportion of types of declaration in 2021 is basically the same as that in the first half of 2021. It is still based on supplementary applications, occupying the entire application type, which is 6089, and there are 2452 clinical acceptance numbers. The acceptance number is 2157, and the number of registered applications is 377. Compared with 2020, the proportion of supplementary applications dropped from 65.21%to 54.98, and the number of clinical and application production increased significantly, raising from 16.85%to 22.14%and from 14.58%to 19.48%. The application type acceptance of each application of CDE drugs in 2020 and 2021 is shown in Figure 4 and Figure 5.

Figure 4 Application Classification in 2020

Data source: medicine wisdom data

Figure 5 Application Classification in 2021

Data source: medicine wisdom data

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

4. Application and completion of the review in 20121

According to the latest statistics from the registration and acceptance of the database, in 2021 (Note: CDE hosting date from January 1, 2021 to December 31, 2021), the number of acceptance numbers is completed The number does not include the end of the review, but the acceptance number of the conclusions of the review is not publicized), of which 4,414 chemical medicines, 206 Chinese medicines, and 792 biological products. See Figure 6 in 2021 and approve the situation.

Figure 6 2021 CDE hosted and approved situation

Data source: medicine wisdom data

5. The end of the review in 20121

According to the latest statistics from the registration and acceptance of the database, in 2021 (Note: State Starting Time (Pharmaceutical Wisdom) from January 1, 2021 to December 31, 2021), the number of acceptance numbers is 1,1210 The number of conclusions is 11021 acceptance numbers, including 7,874 chemical medicines, 1,316 Chinese medicines, and 1,832 biological products. For details of the CDE review of the CDE review in 2021, see Figure 7.

Figure 7 2021 CDE completion review conclusion details

Data source: medicine wisdom data

Data Source: Medicine Registration and Acceptance Database

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