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《保健食品注册管理办法(试行)》规定国产保健食品批准证书变更需经国家食品药品监督管理总局的审批。然而部分保健食品申请人在实际生产经营行为中存在未经审批改变辅料、工艺参数、技术要求等内容的现象。本文通过对上述现象的分析,提出简化国产保健食品变更审批程序的建议,减少国产保健食品申请人办理变更申请所需的物力、人力、时间成本,促进国产保健食品变更工作的正常开展,以期规范国产保健食品生产经营行为。
The Measures for the Administration of the Registration of Health Foods (Provisional) stipulates that the approval of the domestic health food approval certificate shall be subject to examination and approval by the State Food and Drug Administration. However, some health food applicants in the actual production and business practices exist without approval of changing accessories, process parameters, technical requirements and other content of the phenomenon. Based on the analysis of the above phenomena, this paper puts forward the suggestion of simplifying the examination and approval procedure for the change of domestic-made health food, reducing the physical, human and time costs of applying for the change of application for domestic-made health food and promoting the normal change of the domestic-made health food, Domestic health food production and management practices.