自1999年5月1日国家药品监督管理局局令第2号颁布了《新药审批办法》(简称《办法》)以来,有关新药审批注册管理制度日趋完善。在保证人民用药安全上发挥了积极的作用。现就其中新药补充申请的有关问题加以探讨,希望对工作有所帮助。1关于新药补充申请 Since May 1, 1999, the State Drug Administration Order No. 2 promulgated the Measures for the Examination and Approval of New Drugs (the Measures), the management and approval system for registration and approval of new drugs has been perfected. In ensuring the safety of drug use has played a positive role. Now I am going to discuss the relevant issues concerning the application for new drug replenishment and I hope it will be helpful in my work. 1 about new drug application