Traditional Chinese medicine – 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=6.5.6 https://www.accestra.com/wp-content/uploads/2019/03/cropped-accestra2-32x32.png Traditional Chinese medicine – 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

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