On April 30, 2024, the State Administration for Market Regulation (SAMR) issued Technical Requirements for Filing of Health Food Raw Materials Ginseng radix et rhizoma, Panacis quinquefolii radix, and Ganoderma (hereinafter referred to as the “Technical Requirements”), implementing a filing management system for health food products using these three ingredients as raw materials.
The Technical Requirements specify the available excipients, dosage forms, and processes during product filing, clarifying requirements for product quality and safety indicators such as characteristic components and pollutant indicators, which must comply with relevant national food safety standards in China.
This marks the first time that traditional Chinese medicine ingredients for health food have been included in the filing management system. Therefore, it is particularly emphasized that the filed products should comply with traditional consumption methods, consumer groups, and processing techniques.
At the same time, it is required that applicants must possess the ability to process health food products on their own, and that they must have corresponding pre-processing capabilities such as raw material extraction. Those who do not have production conditions temporarily will not be included in the management system.
In addition, to further strengthen the prevention and control of management risks, it’s specified in the Technical Requirements that provincial-level market supervision bureaus, as the filing competent authorities, should regulate according to the technical requirements of the health food raw materials directory, with reference to the current edition of the Pharmacopoeia of the People’s Republic of China and national food safety standards, ensuring that the management of domestically produced health food filings is feasible, manageable, and well-regulated.
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