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瑞旭FAQs丨产品技术要求增订指标的，是只需要提供该指标的稳定性试验，还是提供所有指标稳定性试验？

稳定性试验

2025-01-16

产品技术要求增订指标的，是只需要提供该指标的稳定性试验，还是提供所有指标稳定性试验？

答：建议参照《保健食品注册申请服务指南（2016年版）》产品稳定性重点考察指标和非稳定性重点考察指标，以及注册申请材料等相关要求。例如、增订功效成分或标志性成分指标的，应当参照《指南》5.2.2.4（3）详细说明该功效成分或标志性成分指标选择、指标值制定及其检测方法研究验证的过程和依据，提供研究报告，以及三批样品拟增订功效成分或标志性成分的稳定性试验报告。

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