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On July 24, 2025, China’s State Administration for Market Regulation (SAMR) announced the release of two new regulatory guidelines: the Registration Guidelines for Special Medical Purpose Liquid Formula Foods and the Registration Guidelines for Special Medical Purpose Thickening Component Formula Foods. These guidelines aim to optimize the registration process, production site inspections, and other regulatory requirements of food for special medical purpose(FSMP).
According to Administrative Measures for Registration of Foods for Special Medical Purpose, application materials for FSMP registration include production technique materials, product formula design basis (including stability research materials), and documents proving R&D, production and testing capabilities. To streamline the registration process, certain materials can be simplified, with details listed below:
Product | Condition | Exemption |
Special Medical Purpose Liquid Formula Foods | The production line is shared with registered FSMP nutritionally complete formula, infant formula food for special medical uses, or liquid formula food. In addition, the production technique, parameter design, dosage forms, etc. are basically the same with the registered products. | Not required to submit production technique design basis or relevant literature; only a consistency statement is required. |
The production line is shared with the registered FSMP products. | Not required to submit the original documents proving R&D and production capabilities; only a consistency statement regarding R&D institution, production facility and management system is required. | |
/ | Not required to submit the stability research report; applicants need only clarify the duration of stability research and provide relevant introduction. | |
Special Medical Purpose Thickening Component Formula Foods | The production line is shared with registered FSMP products | Not required to submit production technique design basis or relevant literature; only a consistency statement regarding technique design, dosage form is required. |
The production line is shared with registered FSMP products | Not required to submit the original documents proving R&D and production capabilities; only a consistency statement regarding R&D institution, production facility and management system is required. | |
/ | Not required to submit the stability research report, applicants need only clarify the duration of stability research and provide relevant introduction. |
Furthermore, the Administrative Measures for Registration of Foods for Special Medical Purpose mandates on-site inspections and sampling assessments for FSMP registration. However, the new guidelines provide regulatory relief: when production facilities are shared with registered FSMP nutritionally complete formula, infant formula food for special medical uses, or liquid formula/thickening component formula, and demonstrate equivalent production methodologies, these mandatory inspections can be waived.
To date, SAMR has released the registration guidelines for FSMP products including FSMP for amino acid metabolism disorders, nutritionally complete food, electrolyte formula foods, carbohydrate component formula foods and protein component formula foods.
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