Text: Lisa
Recently, the State Administration for Market Regulation has formulated the "Guidelines for the Registration of Electrolyte Formula Food for Special Medical Purposes", "Guidelines for the Registration of Carbohydrate Component Formula Food for Special Medical Purposes" and "Registration Guide for Protein Component Formula Food for Special Medical Purposes", and announced them.
Source: State Administration for Market Regulation
These three foods have a high degree of consensus, and their clinical application is relatively mature. By optimizing registration management in advance, it is conducive to reducing R&D costs, shortening registration time, improving the efficiency of review and approval, further stimulating the vitality of the special medical food market and meeting the needs of clinical use.
The core information of the document
Significantly simplify the application process for the three foods of "electrolyte formula, carbohydrate component formula, and protein component formula", and enterprises that have been approved and registered for formula food for special medical purposes do not need to submit production process design materials, stability research, R&D capabilities and production capacity and other materials, nor do they need on-site verification and on-site sampling.
●For the registration application of electrolyte formula, carbohydrate component formula and protein component formula in formula food for special medical purposes, if the same production line has been approved for registration, there is no need to submit the production process design basis, literature, etc., and only need to provide a consistency statement.
●In terms of stability study materials, only the time of the study and relevant circumstances need to be stated, and no report is required, but records need to be kept in accordance with the "Requirements for Stability Research on Formula Food for Special Medical Purposes".
●R&D capacity and production capacity materials also only need to submit consistency instructions, no original documents are required. In general, an application for registration that meets the technical requirements does not need to be verified at the production site and sampled, unless it is the first application, the first use of the production line, or other circumstances that need to be verified.
Guidelines for the Registration of Electrolyte Formulas for Special Medical Purposes
The guidelines for the registration of electrolyte formulas for special medical purposes state that the primary purpose of electrolyte formulations is to replenish electrolytes, which should be carbohydrate-based and add appropriate amounts of electrolytes.
It is suitable for people with mild to moderate dehydration due to diarrhea and other reasons.
It is recommended to choose fructose, glucose, maltodextrin, etc. as the source of carbohydrates in the formula, and add electrolytes such as sodium, potassium, and chloride, which can refer to the "New Recommended Implementation Guidelines for the Clinical Management of Diarrhoea" issued by the World Health Organization and UNICEF.
Guidelines for the Registration of Carbohydrate Component Formulas for Special Medical Purposes
A carbohydrate component is a special medical purpose formula designed to replenish carbohydrates and provide energy for people with specific diseases or medical conditions that require additional carbohydrate supplementation.
Its carbohydrate sources include monosaccharides, disaccharides, oligosaccharides, polysaccharides, maltodextrin, glucose polymers and other legal raw materials.
No other nutrients should be added to the formula, and the use of food additives should be necessary for process or use, and meet national standards.
For products containing 12.5 g of carbohydrates per 100 mL in the ready-to-eat state, it is suitable for people who supplement carbohydrates before surgery, and its osmolality should not exceed 320 mOsmol/kg.
Guidelines for the Registration of Protein Component Formulas for Special Medical Purposes
Protein components are designed for people with specific diseases or medical conditions who need protein supplementation, and their protein sources can be protein hydrolysates, peptides, or high-quality whole proteins.
When applying for registration, it is necessary to submit relevant materials including the amino acid score of raw materials and products, the protein digestibility and utilization rate of raw materials, the design basis of raw material composition and dosage, product application, the use and dosage of food additives, and the design basis of protein content, as well as the description and risk assessment of non-protein components.
If the protein source of the product is all high-quality protein (such as whey protein powder, soy protein isolate) and the content exceeds 80%, only the use and dosage design basis of food additives and other excipients need to be provided, and there is no need to submit materials such as amino acid scores.
The following table collates and summarizes the documents related to the application for registration of food for special medical purposes that are currently applicable, and aims to provide applicants with a convenient collection of reference materials to quickly find and compare the relevant requirements and guidelines during the application process.
A compilation of the official documents of the current food for special medical purposes
Source: State Administration for Market Regulation