中美欧药用辅料监管比较分析

摘要

Pharmaceutical excipients are important components affecting drug safety. This work compares excipient regulations and industry practices in China, the US and EU in registration, specification, GMP and GDP requirements and supply chain management, and analyzes the differences of specification, review consideration, review procedures, manufacture and distribution requirements in these three regions mainly from the perspective of registration, to provide references for regulatory agencies and industry organizations.%药用辅料是影响药品安全的重要成分.本文通过上市许可、质量标准、生产和流通要求、供应链管理等方面,对比中国、美国、欧洲的药用监管和行业实践,以上市许可为主线分析三地区对药用辅料的质量标准、审评考虑、审批流程、生产和流通要求的异同,为监管部门和企业提供参考