Progress and Considerations on the Reform of the Pharmaceutical Excipient Joint Review in China
Objective:To propose several suggestions for improving China's pharmaceutical excipient management system by comparing the core elements of China's pharmaceutical excipient joint review and the Drug Master File system in the United States.Methods:A comparative study was made on the six core elements of China's pharmaceutical excipient joint review system and the US DMF registration,including registration scope,registration subject,registration data requirements,integrity review,joint review,and change management.Results and Conclusion:The core elements of China's pharmaceutical excipient joint review system were basically consistent with the US DMF registration system.However,it is not difficult to find that there is room for further improvement in the management of pharmaceutical excipient in China at some conceptual and practical levels,including the risk-based management concept that needs to be further implemented,the significance of registration status needs to be further clarified,and the change management of excipients that can be further optimized.