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申报终产品为阿胶的保健食品,需注意什么?
保健食品
保健食品原料
标志性成分
2023-05-22
       答:根据《关于以红曲等为原料保健食品产品申报与审评有关事项的通知》(国食药监许〔20102号),“终产品为阿胶的保健食品,其产品质量标准应当符合《中国药典》的有关规定”,即标志性成分需制定L-羟脯氨酸、甘氨酸、丙氨酸、L-脯氨酸、特征多肽(以驴源多肽A1、驴源多肽A2计)指标。终产品为阿胶的新产品注册申报时,应按上述要求制定标志性成分。
因特征多肽(以驴源多肽A1、驴源多肽A2计)为《中国药典(2020版)》新增的指标,对于此前已批准的终产品为阿胶的产品,其在申报延续注册、变更注册、转让技术、证书补发时,需增订该指标为标志性成分,并提交该指标三批产品稳定性试验报告。
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