In December, 6 Class 1 new drugs and 2 first copy approvals were approved, and these 6 blockbuster varieties declared new indications

Summary

In December, CDE undertook 1,366 drug registration applications

For the first time, 11 stock varieties have company declaration consistency evaluation

5 Class 1 new drugs are reported for production, and 6 blockbuster varieties have new applications for marketing

In the imitation application, there are no domestically approved 24 varieties

6 Class 1 innovative drugs were approved, of which 3 were Class 1.

2 first imitation varieties were approved, and 8 stock varieties welcomed the first review

CDE overall undertaking

According to the statistics of the MED2.

January-December 2021 CDE-organized drug registration application status (according to the acceptance number)

Consistency evaluation supplementary application undertaking

In December 2021, the supplementary application for consistency evaluation of 61 varieties was undertaken by CDE

CDE Supplementary Application (Consistency Evaluation) Variety Undertaking in December

New drug application undertaking

In December 2021, 169 new drug applications were accepted by CDE

Nanjing Shenghe Pharmaceutical Co.

Undertaking of domestic new drug listing applications in December

The status of domestic new drug clinical applications in December

Undertaking of imitation applications

In December 2021, 159 varieties of imitation applications were undertaken by CDE, of which 24 varieties have not been approved domestically: 10% fat emulsion (OO)/5.

Domestic imitation application undertaking in December

Import application undertaking

In December 2021, import applications for 45 varieties were undertaken by CDE

Undertaking of import listing applications in December

The status of import clinical applications in December

Approval status

In December 2021, Zai Lab's new class 1 drugs, Omacycline tosylate tablets and Omacycline tosylate tablets for injection, were approved for marketing.

43 generic drugs were approved (including imported category 5.

Approval of the variety of application for marketing and the variety of consistency evaluation in December