Purpose

To provide insights into the trends of generic drug development and regulation in China.

Methods

This article reviews the process of generic drug review and approval system reform in China and conducts a data analysis on the application and approval of generic drugs from 2016 to 2020.

Results

In the process of reform, there are many changes in the definition of generic drugs, drug registration classification and ANDA acceptance criteria. A number of policies and regulatory documents were issued, a number of technical guidelines were developed, to cooperate with the reform. From 2016 to 2020, the review efficiency of the ANDA significantly improved, and the numbers of ANDA applications and approvals increased. ANDAs submitted by domestic applicants with RLDs marketed domestically (Registration Category 4) accounted for the largest proportion. The three therapeutic areas with the most ANDA applications were circulatory diseases, anti-infection and oncology. The applications for complex generic drugs accounted for only 7.9% of all ANDA applications.

Conclusions

The review quality and efficiency of the ANDA have been significantly improved in China. With the continuous deepening of reform and improvement of regulatory strategies, more high quality generic drugs will be brought to patients both in China and abroad.