China issues new guidelines to speed up novel drug development

By Wang Fangqing

China’s Center for Drug Evaluation (CDE), a division under the Chinese drug industry watchdog the National Medical Products Administration (NMPA), has been churning out guidelines in the past year to help the nation transform from a generics/biosimilar maker into a novel drug development hub, reports The Pharma Letter’s local correspondent.

The most recent guideline was a draft for rare disease drug development issued on October 11. The draft encouraged drug developers to actively use biomarkers and model informed drug development (MIDD), which includes model-informed dosing, to largely improve clinical study efficiency.