美国化学药品全生命周期变更管理对我国的启示

Enlightenment of life cycle change management of chemicals in USA to China

美国食品药品监督管理局对于化学药品全生命周期的变更管理有程序规范的差异化管理模式。相比较而言,我国对于药品全生命周期的变更管理还有很多改进空间。比如法规的衔接完善、变更检查体系的建立、变更管理的信息化建设和上市后监管措施的融合管理。本文从化学药品的变更法律体系、变更分类和报告、变更电子申报进行分析和介绍,以期对我国的化学药品全生命周期变更管理有所启示。

The US Food and Drug Administration has a differentiated management model with regulations for the change of the whole life cycle of chemical drugs. In comparison, it still has a great space for improvement in the change management of the drug life cycle in China. For example, the connection between laws regulations and guidelines, the establishment of a change inspection system, the informatization of change management, and the integrated management of post-listing regulatory actions. The current article introduces and analyzes the legal system of change management, the classification of the chemical drug change, and sending change electronically, in order to enlighten the chemical drug life cycle change management in China.