Chemical drug – Accestra Consulting https://www.accestra.com Your long term strategic partner for regulatory compliance. Wed, 10 Jul 2019 10:38:46 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.5 https://www.accestra.com/wp-content/uploads/2019/03/cropped-accestra2-32x32.png Chemical drug – Accestra Consulting https://www.accestra.com 32 32 2018 Drug Review and Approval Report of China CDE (Part I-Chemical Drug) https://www.accestra.com/2018-drug-review-and-approval-report-of-china-cde-part-i-chemical-drug/ Wed, 10 Jul 2019 10:27:04 +0000 http://www.accestra.com/?p=2484 On 2nd July, 2019, China CDE-NMPA published the 2018 working Report, summarizing the drug review and approval statistic data in the past year.

See below for the details.

1- Overall Statistic

It can be seen from Figure 1, 2, 3 and 4, the backlog of drug applications in CDE has been greatly alleviated: the application number waiting in line has dropped from nearly 22,000 at the peak of year 2015 to 3,440 in year 2018; the review completion rate for all types of drug applications in 2018 has exceeded 90%.

Figure 1. Drug application total number from 2015 to 2018
Figure 2. Total number of completed drug review by CDE from 2015 to 2018
(By different drug category)
Figure 3. Total number of completed drug review by CDE from 2015 to 2018
(By different application type)
Figure 4. The drug application number waiting in line for CDE review

2- Statistic of Chemical Drugs -Overall

Figure 5. Chemical drug application statistics from 2015 to 2018
Figure 6. Number of completed chemical drug review by CDE in 2018
Table 1 Detailed information of completed chemical drug review by CDE in 2018

*Note: “other” refers: 1) the applicant withdrawal the application, 2) Supplementary information is required from applicant after the review, 3) the application directly submitted to Drug Registration Management Bureau of NMPA instead of CDE, 4) the combination application of medical device, 5) API/excipient/package material application for linked review procedure.

3- Statistic of Chemical Drugs -IND

Figure 7. Therapeutic areas distribution of chemical drugs IND applications in 2018
Figure 8. Indication distribution of innovative chemical drugs IND approved in 2018

4- Statistic of Chemical Drugs -NDA

Figure 9. Chemical drug NDA applications from 2015 to 2018
Figure 10. Approved NDA number from 2015 to 2018 (chemical drugs)

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