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瑞旭FAQs丨拟订的技术要求跟企标一致时，是否要提供产品全项目或稳定性检测报告等作为支持性资料

2025-01-07

拟订的技术要求跟企标一致时，是否要提供产品全项目或稳定性检测报告等作为支持性资料？

答：《换证审查要点》“五、具体要求（七）”，注册人应当在备案或主动公开的执行企业标准基础上，研究制订符合现行规定和国家标准的产品技术要求。涉及增订、修订理化、微生物、功效成分/标志性成分指标的，还需提交修订说明以及相应的卫生学、稳定性、功效成分/标志性成分检测等试验报告等材料。

瑞旭认为，不涉及增订、修订指标的，不需要提供相应的试验报告。

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