美国药品主文件年报递交要求与实践

Requirements and Practice for Submitting the Annual Report of Drug Master File in the United States of America

目的为制药企业向美国递交出口原料药的药品主文件年报更新提供参考。方法梳理美国医药法规及美国食品药物管理局关于药品主文件年报的规定,结合年报递交实践总结相关要求。结果与结论一份完整的药品主文件年报至少包括封面信、行政信息、授权用户的完整列表及自上次年报更新后递交修订的完整列表。

Objective To provide reference for pharmaceutical enterprises to submit annual reports of drug master file( DMF) for active pharmaceutical ingredients( APIs) exported to the United States of America. Methods The regulations of pharmaceutical regulations of the United States of America and guidance on DMF annual report of FDA were reviewed,the relevant requirements were summarized based on the practice of submitting annual reports. Results and Conclusion A complete DMF annual report at least consists of four parts,including cover letter,administration information,a complete list of all parties authorized to make reference to the DMF,and amendments reporting changes since the last annual report.