2019 CDE Annual Drug Review Report: 589 Chemical Class 1 Applications for 1045 ANDA

Release date: 2020-01-07 Views: 0

Source: Yaozhi  

According to the latest statistics of Pharmacognosy Data, in 2019, CDE undertook a total of 8056 new drug registration applications by acceptance number (except for review, the same below). Affected by the new policies related to clinical verification, consistency evaluation, and related drug registration, the number of drugs plunged in 2016 and 2017, and the total number of acceptances decreased significantly. In 2018, the total number of applications basically returned to normal, and in 2019, the total number of applications began to show an increase, of which 6,459 were chemical drugs, 416 were Chinese medicines, and 1,158 were biological products (Figure 1).


Figure 1 CDE drug acceptance situation from 2011 to 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 CDE Drug Acceptance in 2019

In 2018, due to the cut-off point of the consistency evaluation, supplementary applications increased significantly (Figure 3), and the number of supplementary applications in 2019 reached a new height, accounting for 54.12% of the total number of applications accepted in 2019.


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

Figure 3 CDE Drug Application Types Accepted in 2018-2019

In terms of drug declarations by provinces and cities, Jiangsu still led with 930 acceptance numbers, followed by Shanghai, Beijing, Guangdong, and Zhejiang (Figure 4).


Figure 4 Status of declarations by provinces and cities in 2019

Let us analyze the registration and review of chemical medicines, Chinese medicines and biological products.

I. Chemicals

1.Declaration of chemical drugs in 2019

In 2019, CDE undertook a total of 6,459 new chemical registration applications.

From the downturn in 2016 and 2017, chemical drug declarations gradually returned to normal in 2018, and began to rise in 2019 (Figure 5), reaching a peak of 772 in January.


Figure 5 Monthly CDE Chemical Drug Acceptance in 2019

Among the chemical drugs declared in 2019, there were 1,045 ANDA applications, 695 IND applications, 130 NDA applications, and 1,692 supplementary applications. The specific applications are shown in the figure below (Figure 6).


Figure 6 Acceptance of various task types of chemical drugs in 2019

From the perspective of chemical medicine, due to the continuous influence of the cut-off point of consistency evaluation (conformity evaluation varieties are registered and declared as supplementary applications in the registration category), the proportion of registrations for chemical supplementary applications for this year has accounted for 59 % (Figure 7).


Figure 7 Acceptance of CDE chemical drugs by application type in 2019

◆ 1.1 Application of Class 1 New Drugs

According to the current registration classification of chemical medicines, the first category of chemical medicines is defined as: innovative drugs that have not been marketed at home and abroad, including raw materials and their preparations that contain new compounds with clear structure, pharmacological effects, and clinical value. In 2019, 589 new class 1 medicines were declared.


Figure 8 CDE Chemical Class 1 New Drug Acceptance by Month in 2019

The number of applications for each type of chemical medicine category 1 was IND552, NDA21, 12 supplementary applications (clinical), and 4 supplementary applications (pharmaceutical). (Figure 9)


Figure 9 Number of applications for each type of task

◆ 1.2 Declaration of Imported Chemicals

In 2018, a total of 541 applications for the registration of chemical medicines were accepted, including application declarations and clinical varieties.


Figure 10 CDE Import Chemicals Accepted by Month in 2019

◆ 1.3 Acceptance of Consistency Evaluation

Affected by the cutoff point of the consistency evaluation, the consistency evaluation peaked at 207 in January.


Figure 11 Monthly CDE Consistency Evaluation Acceptance in 2019

2.Completion of chemical review in 2019

According to the latest statistics of the Pharmacognosy Registration and Acceptance Database, in 2019 (Note: the status start date is from January 1, 2019 to December 31, 2019), the number of review acceptance numbers (referred to the CDE completed the technical review and transferred to the approval The number of varieties and the processing status includes the status of approval, pending approval, completion of approval or completion of certification, etc., with a total of 2,453, including 1,810 chemical medicines, 261 Chinese medicines, and 370 biological products (Figure 12).


Figure 12 CDE review of various drug types in 2019

Regarding the review of chemical medicines, according to the latest statistics of Pharmacognosy, the number of completed chemical medicines completed this year was 1,285 acceptance numbers, followed by 337 others (Figure 13).


Figure 13 CDE Chemicals Review in 2019

The approval in 2019 is the most supplementary application, followed by the approval of imports. For specific conclusions, please refer to the drug registration and acceptance database of (Figure 14)


Note: The statistical time is January 3, 2020. Statistics at different time points will result in differences in the number of completed trials and the number of evaluation conclusions.

Figure 14 Results of the review of chemical drugs in 2019

Chinese medicine

In 2019, CDE undertook a total of 416 new Chinese medicine registration applications based on acceptance numbers, a decrease of 2.35% compared with 426 in 2018. (Figure 15)


Figure 15 Monthly CDE acceptance of Chinese medicines in 2019

In general, the application of traditional Chinese medicine has been in a relatively sluggish state, with fewer applications for new drugs, and the acceptance numbers are mainly concentrated on supplementary applications. How to change is also worth thinking by the industry.

Third, biological products

In 2018, CDE undertook a total of 1,158 new biological product registration applications based on the number of acceptances, which is an increase of 25.46% compared to 923 in 2018.


Figure 16 Monthly CDE Biological Product Acceptance in 2019

This year, a total of 127 items of Class 1 therapeutic biological products were declared (Table 1).

Table 1 Class 1 therapeutic biological products declared in 2019


Data source: Pharmacognosy registration and acceptance database

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