基于药品管理法修订的美国药品出口管理制度解析

Analysis of Drug Export Administration system in America Based on Revision of the Drug Administration Law

目的为我国《药品管理法》修订之完善药品出口管理制度提供参考。方法通过查阅国内外文献与法规,解析美国药品出口管理制度,分析美国制度优势。结果美国药品出口管理制度具有层次性,关注药品流向,实现出口药品可追溯。结论我国应借鉴FDA出口药品可追溯的管理理念,规定药品出口标识、申请、登记、记录保存要求,规范药品出口秩序,全面掌握药品出口情况。

Objective To provide references for improving Chinese drug export administration in the revision of Drug Administration Law. Methods Domestic and foreign articles and regulations were searched. American drug export administration and its advantages were analyzed. Results The American drug export administration is stratified and focuses on the drug flow in order to make export drugs be traceable. Conclusion We should refer to traceable drug exportation which is the administration idea of FDA, regulate labeling, application, registration and recordkeeping requirements of drug export, and standardize the order of drug export, comprehensively grasp the conditions of drug export.