Food for special medical purpose (hereinafter FSMP) refers to formula foods specially processed and prepared in order to meet special needs for nutrient or diet of those suffering from food intake restriction, disorder of digestive absorption, disorder of metabolic or certain diseases. Such foods shall be used alone or together with other foods under the guidance of a doctor or clinical nutritionist. FSMP is special dietary food, not medicine, but not ordinarily eaten by normal people. It is specially developed by clinicians and nutritionists based on scientific facts after extensive medical research.
Table 1 FSMP for infants between 0-12 months
For more details: SAMR Adjusts Generic Names of FSMP Products
Table 2 FSMP for young children and people over 1 year old
Nutritionally Complete Formula Food
For people aged 1-10 years
For people aged above 10 years
Specific Full Nutritional Formula Food
Nutritionally Incomplete Formula Food
Nutritionally Complete Formula Food: FSMP that can be used as the sole source of nutrition to meet all the nutritional needs of the target population.
Specific Full Nutritional Formula Food: FSMP that can be used as a single source of nutrients to meet the nutritional needs of the target population in specific diseases or medical conditions.
Nutritionally Incomplete Formula Food: FSMP that can meet some of the nutritional needs of the target population, not suitable as a sole source of nutrition.
For more details: Detailed Rules for Licensing and Review of FSMP Production
4. Supervision System
SAMR: State Administration for Market Regulation
NHC: National Health Commission
GAC: General Administration of Customs
4.1 Regulatory Framework
Manufacture & Operation Regulations
Guidelines for Clinical Trails
5. Management Mechanism
5.1 Registration System
Flow Chart 1 Applicant Material Preparation Process (above)
Flow Chart 2 Administrative Process (above)
Requirements & Materials
Domestic applicants: Enterprises manufacture and sell formula food for special medical purpose within the territory of the People's Republic of China.
Overseas applicants: Enterprises that export formula food for special medical purpose to the People's Republic of China.
Having necessary capacities in research and development, production and inspection to produce FSMP.
A research and development institution for FSMP shall be established, with full-time product research and development personnel, food safety management personnel and food safety professional and technical personnel.
Establish production quality management system according to good production specification
Having the ability to inspect all items batch by batch according to the national standard of FSMP.
There shall be persons with senior titles or corresponding professional abilities in research and development institutions.
Registration application form of FSMP;
Product research and development report, product formulation design and basis;
Production process materials;
Product standard requirements;
Product label and specification sample;
Test sample inspection report;
Research and development, production and inspection capability certification materials;
To apply for the registration of specific full nutritional formula food, a clinical trial report shall also be submitted;
Supporting documents related to the registration application.
5.2 Labeling System
It is not allowed for FSMP to claim that it can guarantee the prevention or treatment of diseases.
For more detailed labeling requirements, please refer to: Requirements for Labels and Sample Instructions of Formula Food for Special Medical Purposes (For Trial)
The advertisement of FSMP products should be reviewed by local Administration for Market Regulation before itsissuance.
Consistent with the requirements specified in "Implementation Rules of Food Safety Law," the advertisement for Specific Full Nutritional Formula Food of FSMP is supervised the same as prescription medicines. FSMPs can only be advertised on professional medical and pharmaceutical journals designated by both the health administrative department and drug supervision department under the State Council. Please check ChemLinked News for more details.