药用辅料标准和技术体系建设对我国辅料监管改革的重要作用

Important Roles of Pharmaceutical Excipients Standards and Guidelines System Construction in Excipients Regulatory Reform in China

我国药用辅料一直实行注册审批管理,随着注册制下弊端的不断显现,改革的呼声越来越高,管理模式由注册审批改为登记备案的声音日渐凸显。本文拟在理解登记备案制度的基础上,通过借鉴美国药用辅料的监管经验,从辅料标准和技术体系入手,论述药用辅料标准及技术体系建设对登记备案制实施的积极作用。旨在为药用辅料的监督管理提供对策建议,以期提高药用辅料及药品的质量安全。

Pharmaceutical excipients are implementing registration and approval management in our country. As the disadvantages of the registration system appearing continuously, the demand for reform is getting higher and higher. The cry for drug master files （DMF） model instead of registration and approval management is becoming more prominent. Based on the understanding of DMF system, the article discussed the positive roles of the excipients standards and guidelines construction in DMF implementation using pharmaceutical excipients supervision experience in the United States as the reference and starting from the standards and guidelines system of excipients, which aimed to provide suggestions for the supervision and management of pharmaceutical excipients, and improve the quality and safety of pharmaceutical excipients and drugs.