Editor's Notes: Drug registration applications in China include
clinical trial applications (CTA);
marketing authorization application (MA);
post-market supplemental applications;
drug license renewal application.
The past six years has seen a robust growth of drug registration applications in China. From 2016 to 2021, the number of drug registration applications accepted by China Center for Drug Evaluation (CDE) climbed from 3,779 to 11,569.1
Among the applications last year, 8,174 were for chemical drugs, 2,022 for biological products, and 1,371 for traditional Chinese medicines (TCMs).
Drug Registration Applications Accepted by China CDE in 2021, source: Yaozh Database
1,439 applications were for domestic Class 1 innovative drugs, including 1,383 for clinical trials and 52 for marketing authorization. Among the domestic Class 1 innovative drug applications, 896 are for chemical drugs, 489 for biological products (481 therapeutic and 8 prophylactic), and 54 for TCMs.
Domestic Innovative Drug Applications Accepted by China CDE in 2021, Source: Yaozh Database
In terms of applications for importing drugs, CDE accepted 169 applications for importing Class 5.1 branded drugs which had received marketing authorizations outside China.
CDE also accepted applications for importing innovative drugs which had never received marketing authorization in or outside China. Among the applications, 264 were for Class 1 innovative chemical drugs, 133 for Class 1 therapeutic biologics, and 1 for Class 1.1 prophylactic biological product.
RELATED: China Chemical Drug Registration Classification; China Biological Product Registration Classification
Behind the remarkable numbers of drug registration applications are pharmaceutical companies seeking opportunities in the Chinese market.
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