一、 行业新阶段：在规范与重塑中探寻发展路径中药注射剂行业的发展环境已发生根本性变化，正从规模扩张转向质量提升的新阶段。 政策监管趋严倒逼产业升级。 近年来，国家药品监管部门对中药注射剂的监管力度持续加大，相关政策密集出台。这些政策的核心聚焦于提升产品质量标准、加强全生命周期安全性研究、规范临床使用以及推动上市后再评价。近期，国家药监局再次强调对中药注射剂原料药材的源头控制、生产过程的精细化管理和...
Source Link一、 行业新阶段：在规范与重塑中探寻发展路径中药注射剂行业的发展环境已发生根本性变化，正从规模扩张转向质量提升的新阶段。 政策监管趋严倒逼产业升级。 近年来，国家药品监管部门对中药注射剂的监管力度持续加大，相关政策密集出台。这些政策的核心聚焦于提升产品质量标准、加强全生命周期安全性研究、规范临床使用以及推动上市后再评价。近期，国家药监局再次强调对中药注射剂原料药材的源头控制、生产过程的精细化管理和...
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