Biological products – Accestra Consulting https://www.accestra.com Your long term strategic partner for regulatory compliance. Fri, 12 Jul 2019 06:06:23 +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 Biological products – Accestra Consulting https://www.accestra.com 32 32 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

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