National Chinese Medicine Variety Protection Review Committee:
The China Nutritional Health Food Association (hereinafter referred to as the “Association”) attaches great importance to issues related to the registration of special medical foods with different characteristics, different food forms and different specifications. According to the recommendations of the commission, the association and the European Union Chamber of Commerce in China convened nine domestic and foreign special medical food enterprises, and held a meeting on August 27 to discuss relevant issues. After the meeting, the association will sort out relevant issues and suggestions, and hereby for your reference. The details are as follows:
I. Differences of FSMP with the same product characteristics
FSMP produced by the same manufacturer with the same product characteristics may include different flavors, different food forms, different packaging specifications, different packaging materials, etc. Different conditions may correspond to different raw material sources, production processes, product shelf life, and food consumption. Mode, clinical use, etc.
II. The main considerations to whether to give the same registration approval number
(1) Whether the product safety, nutritional adequacy and clinical effect are consistent;
(2) the difference in clinical use of the product;
(3) considerations regarding consumer selection and use;
(4) streamlining the number of approved products and saving regulatory resources;
(5) International practices.
III, different flavor products with the same product characteristics
For the same company, the products with the same product characteristics have the same clinical effect, and the clinician or clinical dietitian will guide the use of these products according to the patient's specific conditions. Different flavors of products have different formulation differences, as follows:
(1) The difference in product taste comes from the essence.
(2) The difference in taste of products comes from natural raw materials such as fruit and vegetable powder.
IV, The same product with different packaging specifications
only the same product with different packaging specifications will not affect the safety, nutritional adequacy and clinical effects of the product, and will not affect the characteristics of the product.
It is recommended that for different specifications of products, the same registration approval number is given as the same product; the determination of the shelf life of the product is the responsibility of the enterprise, and it is not necessary to provide stability studies under different specifications.
V, The same product of different packaging materials
The use of different packaging materials for the same product will not affect the safety, nutritional adequacy and clinical effects of the product, and will not affect the product characteristics; it may have a certain impact on the stability of the product, and at the same time, different materials may be different. Migration parameters.
It is recommended to give the same registration approval number for the same product of different packaging materials, and also require the company to submit the arguments and explanatory materials related to the differences caused by different packaging materials.
VI. Food products with the same characteristics but different forms
The food form of special medical foods is usually powdery and liquid. In the case of the same nutrient composition table, the production process is different, the production line is different, the applicable population may be different, the raw materials are obviously different, and the formula dosage table is different. It is a big difference. Consumers also have different considerations when purchasing.
It is recommended to give different registration approval number for this kind of situation and manage according to different products.
