2020 Annual Drug Evaluation Report

The Center for Drug Evaluation approved 28 Chinese medicine IND applications and 4 Chinese medicine NDAs (Lianhua Qingke Tablets, Jingu Pain Gel, Mulberry Twig Total Alkaloid Tablets, and Mulberry Twig Total Alkaloids)
.
The detailed status of the review of various types of registration applications for Chinese medicines in 2020 is shown in Table 2, and the review and approval of TCM IND applications and the review of TCM NDAs in 2016-2020 are shown in Figure 4
.

The Center for Drug Evaluation has approved 28 TCM IND applications, covering 10 indications
.
Among them, there are 7 cases of breathing, 4 cases of orthopedics, and 4 cases of digestion, accounting for a total of 53.
57%.
The distribution of indications for Chinese medicine IND applications approved in 2020 is shown in Figure 5
.

(3) Completion of review of application for registration of chemical drugs

1.
Overall situation

In 2020, the Center for Drug Evaluation will complete 6,778 chemical drug registration applications reviewed
.
Among them, a total of 1086 chemical drug clinical applications (IND applications and confirmatory clinical trials) were completed, an increase of 45.
58% compared with 2019; 163 chemical drug NDAs were completed; 1697 chemical drug ANDAs were completed; 1136 conformance evaluation applications were completed, compared with 2019 An annual increase of 103.
22%; 2248 supplementary applications for chemical drugs were completed, an increase of 23.
72% over 2019
.
Refer to Figure 6 for details of the review completion status of various registration applications for chemical drugs in 2020
.

2.
Approval status

Among the chemical drug registration applications reviewed by the Center for Drug Evaluation, 907 IND applications were approved, an increase of 51.
42% over 2019; 115 NDAs were reviewed, an increase of 30.
68% over 2019, and 918 ANDAs were reviewed.
This is an increase of 15.
33% compared to 2019
.
The detailed status of the review of various registration applications for chemical drugs in 2020 is shown in Table 3
.

The Center for Drug Evaluation has completed review of 960 chemical drug IND applications, and approved 907 IND applications
.
Among them, there were 694 IND applications (298 varieties) for category 1 innovative chemical drugs, an increase of 40.
77% compared with 2019, and the number of varieties increased by 57.
67% compared with 2019
.
Refer to Figure 7 for details of the approval of IND applications for chemical drugs and category 1 innovative chemical drugs during the 2016-2020 review
.

Among the 694 Class 1 innovative chemical drugs reviewed and approved by the IND application by the Center for Drug Evaluation, there are more anti-tumor drugs, anti-infective drugs, circulatory system disease drugs, endocrine system drugs, digestive system disease drugs, rheumatic diseases and immune drugs.
It accounts for 80.
69% of the total number of clinical trials approved for innovative drugs
.
The distribution of indications for IND applications for Class 1 innovative chemical drugs approved in 2020 is shown in Figure 8
.

A total of 163 chemical drug NDAs have been reviewed by the Center for Drug Evaluation
.
Among them, 115 NDAs for chemical drugs were reviewed, and 14 NDAs for category 1 innovative chemical drugs were reviewed
.
Refer to Figure 9 for details of the NDA approval status of chemical drugs from 2016 to 2020
.

The Center for Drug Evaluation has completed 1,136 applications for consistency evaluation, and 577 passed the evaluation
.
Among them, 456 applications for consistency evaluation of oral solid preparations were approved for review and 121 applications for consistency evaluation for injections were approved
.
For specific varieties, see Annex 3 .
Refer to Figure 10 for details of the consistency evaluation applications approved during the 2018-2020 review
.