China had a backlog of more than 18,500 drugs awaiting approval by the end of 2014, an increase of 33% from the previous year, according to the China FDA's Center for Drug Evaluation.
The jump reflects growing official and industry views that a refined approval process started two years ago to both check safety and bring products to market more quickly has not delivered.
China's drug trial center received 8,868 drug applications in 2014, up from 7,610 the year before, according to the annual report released on Friday in Chinese.
The organization increased the number of reviews it completed last year and hired a new group of professionals with industry experience, but was overwhelmed by an increase in applications.
"This has further increased the backlog of pending tasks," it said.