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In November, CDE undertook a total of 963 drug registration applications; For the first time, 7 existing varieties had the consistency evaluation of enterprise declaration; 3 Class 1 new drugs were reported for production, of which 2 were proprietary Chinese medicines; There are 27 varieties of imitation applications that have not been approved domestically; 3 Class 1 new drugs, 3 imported original research to be approved; 7 first generic varieties were approved, and 6 existing varieties were evaluated for the first time
.
Overall CDE Undertaking
According to the statistics of Minai.
com China Application Progress (MED) database, CDE undertook a total of 963 drug registration applications in November 2022
.
Status of CDE drug registration applications from January to November 2022 (by acceptance number)
Consistency evaluation of supplementary application undertaking
In November 2022, the supplementary application for consistency evaluation of 48 varieties was undertaken by CDE
.
Amoxicillin clavulanate potassium dry suspension (14:1), pyrilaster potassium tablets, compound electrolyte injection (II.
), mitiglinide calcium tablets, ribapod tablets, telmisartan hydrochlorothiazide tablets, metoclopramide hydrochloride injection and other 7 varieties are declared for the first time
.
CDE supplementary application (consistency evaluation) varieties undertaken in November
New drug application undertake
In November 2022, 83 varieties of new drug applications were undertaken by CDE
.
There are 63 Class 1 new drugs, including 6 proprietary Chinese medicines, 19 Class 2 improved new drugs, and 1
biosimilar.
Jiangsu Wanbang Biochemical Pharmaceutical's Class 1.
1 proprietary Chinese medicine Peony Relief Tablets and Jiangsu Zhuohe Pharmaceutical's Class 1.
1 proprietary Chinese medicine Feng Ye Cough and Asthma Oral Liquid were declared for marketing
.
Shenyang 3SBio's recombinant human thrombopoietin injection and CSPC Mingfule Pharmaceutical (Guangzhou) recombinant human TNK tissue plasminogen activator for injection are new
indications 。
Domestic new drug marketing application in November
Domestic new drug clinical application undertaking in November
Acceptance of imitation applications
In November 2022, the generic application of 130 varieties was undertaken by CDE, including 6-[18F]fluoro-L-dopa injection, oxcarbazepine oral suspension, fluticasone propionate nebulized inhalation suspension, ibudrocodone tablets, acetic acid maintenance solution (containing glucose), a variety of trace element injection (III.
), fenofibrate tablets (III.
), fesoterodine fumarate sustained-release tablets, tanduspirenone citrate tablets, sildenafil citrate dry suspension, calcitriol injection.
.
.
and other 27 varieties, currently no domestic generic drugs have been approved
.
Domestic imitation application undertaking in November
Acceptance of import applications
In November 2022, the import application of 43 varieties was undertaken by CDE
.
Among them, there are 21 Class 1 new drugs, 5 Class 2 improved new drugs, 10 Class 5.
1 imported original drugs, and 5 Class 5.
2 imported generic drugs
.
Import listing application in November
Import clinical application undertaking in November
Approval
In November 2022, Tianjin Hongri Jiandakang Pharmaceutical, Shanghai Yingli Pharmaceutical, Shandong Luye Pharmaceutical, etc.
all had Class 1 new drugs approved for marketing
.
Shanxi Zhendong Anxin Biopharmaceutical's colloidal pectin bismuth granules were approved
as new dosage forms.
Merck's pembrolizumab injection was approved for new indications
.
81 generic drugs were approved for marketing (including imported class 5.
2), pimecrolimus cream (Jiangsu Zhiyuan Pharmaceutical), azastine fluticasone nasal spray (Changfeng Pharmaceutical), a variety of oil fat emulsion injection (C6-24) (Fresenius Kabihuarui Pharmaceutical), Eggestat tartrate capsules (Beijing Gloria Tiancheng Pharmaceutical), clopidogrel aspirin tablets (Lepu Pharmaceutical), potassium chloride oral solution (Hangzhou Heze Kunyuan Pharmaceutical), sorbitol mannitol rinse (Jimin Health Management) is the first imitation variety
in China.
26 stock varieties have been evaluated by enterprises, and 6 stock varieties, including compound α-ketoacid tablets, rupatadine fumarate tablets, pantoprazole sodium enteric-coated capsules, dronedarone hydrochloride tablets, tirofiban hydrochloride concentrated solution for injection, and piperacillin sodium for injection, have been evaluated
by enterprises for the first time.
Approval of listing application varieties and consistency evaluation varieties in November
Data sources: MED2.
0 drug evaluation database, CDE, NMPA; The relevant statistical fields are counted by drug name, as of November 30, 2022; Drug targets and indications are compiled from public information
.
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