Regulation

Drug Master File system of China （Part 2）

Chapter 2 How to file DMF in China? I have introduced something about the background, basic requirements of China DMF system in the previous article.

Drug Master File system of China （Part 1）

Chapter 1 Introduction on Bundling review Regulation in China 1. Introduction Since China drug regulation reform from 2015, China Food and Drug Adm

China NMPA’s observations of ‘flight inspection’ on medical devices

In 2023, the China NMPA(National Medical Products Administration) conducted ‘flight inspections’ (unannounced inspections) to 20 medical d