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CDE答复：化学仿制药采用辐照灭菌工艺的相关要求

发布时间：2026-09-30 00:00:00

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CDE答复：化学仿制药采用辐照灭菌工艺的相关要求


   9月29日，国家药监局药审中心（CDE）官网刊登了“化学仿制药关系问题”之一的“化学仿制药采用辐照灭菌工艺的相关要求？”的答复。

问：化学仿制药采用辐照灭菌工艺的相关要求？

答：辐照灭菌工艺为相对特殊的灭菌工艺，通常情况下，药品生产企业可能不具备辐照灭菌的生产条件。若原研药品采用辐照灭菌工艺，且经综合评估确认其他灭菌方式无法达到相应的无菌保障水平，仿制药可考虑采用辐照灭菌工艺生产，如自身不具备辐照灭菌生产条件的，可以委托其他企业进行辐照灭菌。 
申请人应提供如下资料：
（1）辐照灭菌生产的具体情况。
（2）辐照灭菌企业的相关资质文件，辐照灭菌过程的GMP符合性情况。
（3）药品采用辐照灭菌工艺的必要性及合理性。
（4）转运、灭菌环节采取的风险防控措施等。必要时可与药审中心进行沟通。 
在产品批准前，申请人应与相关监管机构沟通，完成GMP符合性检查（包含辐照灭菌场地）。
​药品上市许可持有人应当严格履行主体责任，将转运、灭菌环节纳入其质量管理体系，对制剂生产、转运及委托灭菌全过程加强质量控制，确保药品质量安全。
辐照灭菌企业应当遵守药品GMP，并在申报药品注册时承诺在相关药品全生命周期内接受药品监督管理部门的检查。
持有人所在地省级药品监管部门应当对辐照灭菌公司纳入上市后药品监管范围，确保其按照核定的工艺进行转运和灭菌，确保持续符合GMP的要求。 
药品上市后，如拟变更辐照灭菌企业的，应当按补充申请申报，除按照药品上市后变更有关技术指导原则开展研究、提供资料外，还应当按照本问答第二款提交相关资料。


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