Pharmaceutical excipients are essential ingredients for drug products. The quality and safety of excipients directly impact the safety and efficacy of drug products. Some drug safety events in recent years have revealed the safety risks induced by pharmaceutical excipients. It becomes more and more urgent to reinforce the administration of pharmaceutical excipients. However，there’s no specific regulation on administration of pharmaceutical excipients yet. In spite of the strengthen of routine supervision，it is worth to discuss in depth how to combine the risk management philosophy during the approval process，therefore to control the safety risks brought by pharmaceutical excipients at the source. Through the comparisive study on the administration of pharmaceutical excipients between home and abroad，as well as the investigation on the status quo of manufacture and application of excipients at local and other provinces，this research aims to analyse the practical problems existed currently and figure out countermeasures to improve the local administration of excipients，hence to better control the safety risk from excipient and facilitate the development of pharmaceutical industry. This research also gives recommendations on risk management and new registration approaches for pharmaceutical excipient.