药用辅料是指制剂中加入的除活性成分外其他成分的总称,药用辅料登记备案、关联审评审批是我国全过程监管药品生产和质量的重大举措。我国已上市的药用辅料总数为500多种,而对于不同规格的辅料的注册过程较长,因此,企业对多规格辅料的研发、服务成为国产辅料的瓶颈,备案制可以缩短审批周期,促进和加速不同规格药用辅料的应用。本文阐述了药用辅料登记和关联审评审批的意义,对实施情况进行了回顾并展望。
<<Pharmaceutical excipients were the general name of the ingredients other than active ingredients in the preparations. The registration and filing of pharmaceutical excipients and the relevant review and approval were major measures for the whole-process supervision of drug production and quality in China. The total number of pharmaceutical excipients that were sold in the market in China was more than 500,and the registration processes for excipients with different specifications were long. Therefore,the research and development and service of multi-specification excipients had become the bottleneck of domestic excipients. The filing system could shorten the review and approval cycle,and promote and accelerate the application of pharmaceutical excipients with different specifications. This report described the significance of the registration and relevant review and approval of pharmaceutical excipients,reviewed the implementation and made predictions.
<<Keywords: | Pharmaceutical ExcipientsRegistration and Filing of Pharmaceutical ExcipientsRelevant Review and Approval. |