关联审评制度下药用辅料质量标准浅析

目的：研究关联审评制度下药用辅料质量标准现状,帮助理解关联审评制度下药用辅料质量标准内涵和各质量标准间存在的关系。方法：详细介绍关联审评制度下药用辅料质量标准的分类及特点,着重对现行药用辅料备案管理制度和药用辅料备案标准的制定要求、状态、变更、效力和现状等进行系统归纳、阐述,同时也对药用辅料备案标准和药典标准间的关系进行了分析、探讨。结果与结论：药品辅料的质量标准是药用辅料质量的重要衡量尺度,包括药典标准、注册标准、备案标准和内控标准等,其中药用辅料药典标准是对该辅料质量控制的基本标准和门槛;关联审评新制度下产生的药用辅料备案标准是监管机构确认辅料质量的重要文件。在关联审评制度的新时期,在进一步加深对药用辅料各质量标准的内涵和关系理解的同时,一方面需要企业对其备案的药用辅料进行更加广泛、深入的研究,以便给审评人员在关联审评时提供更多的参考依据;另一方面需要监管机构持续完善我国药用辅料药典标准体系,促进国内药用辅料质量标准整体提升,有助于提高我国制剂整体质量、推进制剂创新发展。

Analysis of the Quality Standard for Pharmaceutical Excipients under the Bundling Review System

Objective: To study the status of pharmaceutical excipients quality standards under the bunding evaluation system, in order to help fully understand the connotation of pharmaceutical excipients quality standards and the relationship between quality standards under the bunding evaluation system. Methods: The classifi cation and characteristics of the quality standards of pharmaceutical excipients under the bunding evaluation system were introduced in detail, and the requirements, status, changes, effectiveness and status of the current filing management system of pharmaceutical excipients and the filing standards of pharmaceutical excipients were systematically summarized and expounded. At the same time, the relationship between the fi ling standards and pharmacopoeia standards of pharmaceutical excipientswere analyzed and discussed. Results and Conclusion: The quality standard of pharmaceutical excipients is an important measure of the quality of pharmaceutical excipients, including pharmacopoeia standard, registration standard, fi ling standard and internal control standard, among which the pharmacopoeia standard of pharmaceutical excipients is the basic standard and threshold for the quality control of the excipients. The fi ling standard of pharmaceutical excipients produced under the new system of bunding review is an important document for regulators to confi rm the quality of excipients. In the new era of the bunding evaluation system, while further deepening the understanding of the connotation and relationship of the quality standards of pharmaceutical excipients, on the one hand, it is necessary for enterprises to conduct more extensive and in-depth research on the pharmaceutical excipients they have fi led in order to provide more reference basis for the reviewers in the bunding evalutaion; On the other hand, it is necessary for regulatory agency to continue to improve the pharmacopoeia standard system of medicinal excipients in China, and promote the overall improvement of the quality standards of domestic medicinal excipients, so as to lay a solid foundation for improving the overall quality of preparations in China and promoting the innovation and development of preparations.