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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。
China’s pharmaceutical excipients have been implemented registration and approval management, with the drawbacks of the registration system continues to emerge, the voice of reform is getting higher and higher, the management mode by the registration approval to the registration filing voice increasingly prominent. This article intends to understand the registration filing system, based on the experience of the United States through the supervision of pharmaceutical excipients, starting from the excipient standards and technical systems, discusses the pharmaceutical excipients standards and technical system construction on the registration filing system to implement the positive role. The purpose is to provide suggestions for the supervision and management of pharmaceutical excipients, with a view to improving the quality and safety of pharmaceutical excipients and drugs.