Drug Registration Regulation
New Drug Applications (NDA)
2020 Annual Drug Evaluation Report
The Center for Drug Evaluation
Writer: Minhua Chu
Charts: Danni Yin
Editor: Justin Fischer
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has completed 11,582 registration applications for Chinese medicines, chemical drugs, and biological products. The amounts to a total increase of 32.67% from 2019 despite the pandemic. Among them, 8,606 registration applications are subject to technical review.
China has been accelerating its review and approval process in recent years after a series of new regulatory policies and guidelines. The number of registration applications pending review and approval has been reduced from nearly 22,000 at the peak of September 2015 to 4,882 at the end of 2020.
Last year, 1,561 Investigational New Drug (IND) applications were accepted among the 8,606 registration applications, an increase of 55.94% compared with 2019. CDE approved 1,435 IND applications, an increase of 54.97% since 2019.
289 New Drug Applications (NDA) reviews have been accepted and completed, of which 208 passed the review process, an increase of 26.83% since 2019. Among them, the CDE reviewed and approved 20 NDAs for innovative drugs and 72 NDAs for original drugs produced overseas including varieties with new indications.
The CDE accepted a total of 1,062 applications for the registration of Class 1 innovative drugs, an increase of 51.71% since 2019. China classifies Class 1 innovative drugs as new drugs which have never been marketed within or outside China. 1,008 IND applications (559 varieties) were accepted, an increase of 49.78% since 2019. 54 NDA applications (38 varieties) were accepted, an increase of 100.00% since 2019. 843 of them were produced in China, 219 overseas.
1,700 generic drugs have completed Abbreviated New Drug Application (ANDA) review last year. 918 were approved. To improve the quality of generics, drug manufacturers have been required to conduct generic drug quality and efficacy consistency evaluation since 2016. In 2020, 1,136 generic drugs have completed the application. 577 applications were approved, an increase of 121.92% since 2019.
The revised Drug Registration Regulation that came into effect in July 2020 adopts similar FDA priority programs to encourage innovation. It allows the review process to be expedited under four circumstances, including special approvals, breakthrough therapies, conditional approvals, and priority review. In principle, the review process is supposed to be completed within 200 working days. With a priority review, the timeframe can be reduced to 130 working days or even 70 working days for overseas drugs that address urgent clinical needs and target rare diseases.
In accordance with the NMPA's Working Procedures for Review of Breakthrough Therapeutics further clarifies the scope and conditions for application, working procedures and support policies in these expedited channels.
In fighting against the COVID-19 pandemic, the expediting process green-lit 59 registration applications for COVID-19 vaccines and other treatments through the special approval channel. 53 of the applicants were approved for clinical trials.
In 2020, 24 drugs were included in the breakthrough therapy channel. 15 were listed under conditional approval, covering diseases caused by the novel coronavirus, non-small cell lung cancer, ovarian cancer and other indications. A total of 217 drugs passed the priority review procedure, an increase of 51.7% compared with 2019. They included locally developed innovative drugs Almonertinib, Zanubrutinib and Orelabrutinib.