CDE 2018 report – Accestra Consulting https://www.accestra.com Your long term strategic partner for regulatory compliance. Fri, 12 Jul 2019 06:25:41 +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 CDE 2018 report – Accestra Consulting https://www.accestra.com 32 32 2018 Drug Review and Approval Report of China CDE (Part III- Traditional Chinese Medicine) https://www.accestra.com/2018-drug-review-and-approval-report-of-china-cde-part-iii-traditional-chinese-medicine/ Fri, 12 Jul 2019 06:25:40 +0000 http://www.accestra.com/?p=2519 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.

8- Statistic of Traditional Chinese Medicine – Overall

Figure 17. Traditional Chinese medicine application total number from 2015 to 2018
Figure 18. Traditional Chinese medicine application statistics in 2018
Figure 19. Number of completed traditional Chinese medicine review by CDE in 2018
Table 3 Detailed information of completed traditional Chinese medicine 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.

9- Statistic of Traditional Chinese Medicine -IND

Figure 20. Approved number of traditional Chinese medicine IND application from 2015 to 2018
Figure 21. Indication distribution of traditional Chinese medicine IND approved in 2018

10- Statistic of Traditional Chinese Medicine -NDA

Figure 22. Approved number of traditional Chinese medicine NDA application from 2015 to 2018

]]> 2018 Drug Review and Approval Report of China CDE (Part II-Biological products) https://www.accestra.com/2018-drug-review-and-approval-report-of-china-cde-part-ii-biological-products/ Fri, 12 Jul 2019 05:17:36 +0000 http://www.accestra.com/?p=2508 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.

5- Statistic of Biological Products – Overall

Figure 11. Biological products application total number from 2015 to 2018
Figure 12. Biological products application statistics in 2018
Figure 13. Number of completed biological products reviewed by CDE in 2018
Table 2 Detailed information of completed biological products 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.

6- Statistic of Biological Products -IND

Figure 14. Approved number of biological products IND application from 2015 to 2018
Figure 15. Therapeutic areas distribution of biological products IND applications in 2018

7- Statistic of Biological Products -NDA

Figure 16. Approved number of biological products NDA application from 2015 to 2018

]]> 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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