China Food for Special Medical Purposes Registration

      Food for special medical purposes referred to as FSMP. According to data from Report Linker, the global FSMP market scale will reach US$19.65 billion in 2022, and is expected to grow steadily at a compound annual growth rate of 7% from 2022 to 2027. China’s FSMP industry started late and is currently relatively small in scale. However, it has shown a good development trend in recent years and has an objective market prospect. As of January 3, 2024, a total of 164 foods for special medical purpose registrations have been approved (of which 5 have applied for cancellation), 132 are domestically produced and 32 are imported. Among the 164 approved products, the majority are in powder form, with 122 products in powder form and the remaining 42 in liquid form.

      China has continuously introduced a number of policies related to FSMP to promote the high-quality development of this industry. The country has successively released the “Healthy China 2030 Planning Outline” and the “National Nutrition Plan (2017-2030)”.

      The “Healthy China 2030 Planning Outline” aims to establish and improve a residents’ nutrition monitoring system and implement nutrition intervention in key areas and key groups. The goal of this “Planning Outline” is to achieve a significant improvement in residents’ nutritional knowledge and literacy and a significant decrease in the incidence of nutritional deficiencies” by 2030.

      The “National Nutrition Plan (2017-2030)” proposes to strengthen the construction of clinical nutrition departments so that the ratio of clinical nutritionists to beds reaches 1:150 and promote the standardized application of FSMP and therapeutic diets. Besides, it needs to further study and improve the standards for food for special medical purposes, refine product classification, and promote the research, development and production of food for special medical purposes.

      China has a large population base, an increasing number of chronic patients, and an increasingly serious aging problem. Specific whole nutrition formula food have great development potential in the future and are worthy of long-term layout, increased investment, and early market deployment by enterprises.

      If you want to know more about China’s market of food for special medical purpose, please can contact us.

Definition of Food for Special Medical Purposes

      Food for Special Medical Purposes (hereinafter referred to as FSMP) refer to formula food specially processed and formulated to meet the special needs of nutrients or meals for people with dietary restrictions, digestion and absorption disorders, metabolic disorders or specific disease states. FSMP plays an important role in nutritional support for patients’ disease treatment, recovery, and maintenance of body functions. Its quality and safety are related to the health and life safety of special groups.

Legal Basis of FSMP

• “Food Safety Law of the People’s Republic of China”
• “Registration and Management Measures for Foods for Special Medical Purposes”

      (The new version of the management measures revised and issued by the State Administration for Market Regulation will be implemented from January 1, 2024. The “Measures of Registration Management of Foods for Special Medical Purposes” promulgated by the former State Food and Drug Administration Order No. 24 on March 7, 2016 shall be abolished at the same time)

• Relevant national standards and supporting documents of regulations

1. GB 25596 Infant formula for special medical purposes
2. GB 29922 General rules for foods for special medical purposes
3. GB 29923 Good Manufacturing Practice for Foods for Special Medical Purposes
4. GB 13432 National Food Safety Standard Prepackaged Special Dietary Food Labels
5. Registration and Management Measures for Foods for Special Medical Purposes
6. Registration application materials and requirements for foods for special medical purposes (Trial) (2017 revised version)
7. Stability research requirements for foods for special medical purposes (Trial) (2017 revised edition)
8. Requirements for labels and sample instructions for foods for special medical purposes (Trial)
9. On-site inspection key points and judgment principles for registered manufacturers of foods for special medical purposes (Trial)
10. Good Management Practices for Clinical Trials of Foods for Special Medical Purposes (Trial)
11. Technical Guiding Principles for Clinical Trials of Specific Whole Nutrition Foods Diabetes/Kidney Disease/Tumor
12. Review details for production license of foods for special medical purposes

Application Process of FSMP

      The registration application of food for special medical purposes is mainly divided into formal review, technical review, data supplement and correction, and on-site verification.

Q&A About Food for Special Medical Purposes

Q1: Is food for special medical purposes are health foods or medicines?

A1: Food for special medical purposes, neither a health product nor a medicine, but it is not an ordinary food eaten by normal people. For people with dietary restrictions, digestive and absorption disorders, metabolic disorders or specific disease states, it is difficult to meet nutritional needs through normal diet. At this time, food for special medical purpose are needed as a nutritional supplement method to provide nutritional support, such as infants with allergic symptoms need partially hydrolyzed or deeply hydrolyzed milk protein or amino acid formula foods, etc. The consumption method and amount of this type of food should be determined comprehensively according to the age, weight and medical status of the applicable population under the guidance of a doctor or clinical nutritionist. It can be used alone or in combination with ordinary food or other special dietary foods.

In view of the specific metabolic states of different diseases, FSMP have special regulations on the corresponding nutrient content, which can better adapt to the nutritional needs of specific disease states or a certain stage of the disease, and provide targeted nutritional support to patients. It is an effective way to provide clinical nutrition support. However, such food is not medicines and cannot replace the therapeutic effects of medicines. Products must not claim to prevent or treat diseases. Regardless of the function, form, ingredients and clinical uses of the product, its functions are closer to that of food. Therefore, at the regulatory level, China, like other countries, has included FSMP in the food supervision system.

Q2: Do FSMP need registration or filing?

A2: China implements a very strict access system for FSMP—product registration system.