Under China’s Food Safety Law, food is categorized into general and special food, the latter including health food, food for special medical purposes (FSMP), and infant formula food. FSMP is specially processed and formulated to meet the unique nutritional or dietary needs of individuals with dietary restrictions, digestive and absorption disorders, metabolic disorders, or specific diseases. FSMP in China is subject to registration management and must be used under the guidance of a physician or clinical nutritionist.
While FSMP is a relatively new concept in China, its market is rapidly expanding. Despite initial challenges, including a weak industrial foundation, insufficient product development, and limited access and awareness, significant progress has been made in recent years.
As of August 15, 2024, 190 FSMP products from 64 companies have been registered, covering all product categories. This growth has been particularly evident since 2023, with 102 FSMP products registered, exceeding the total number registered in the previous six years. Domestic products now dominate the market, accounting for over 80% of approvals since 2020. While infant formula and complete nutrition products lead to approvals, products for specific diseases and rare diseases remain scarce. Currently, only 1.6% of malnourished patients in China use FSMP, a significant gap compared to developed countries like the United States (65%).
China's regulatory landscape for FSMP is evolving to prioritize clinical nutrition needs and expedite the approval process for urgent needs. This commitment is evident in a series of regulatory updates and initiatives:
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November 2023
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The "Registration Management Measures for FSMP" were revised and released, streamlining the process and shortening review times. |
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December 2024 |
The "Announcement on the Management of Amino Acids in Special Dietary Foods" was issued, allowing domestic amino acid manufacturers to obtain production licenses for nutritional fortifiers. Amino acid metabolic disorder formulas remain scarce, with only 3 approved products, all imported. |
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May 2024 |
The "Quality Management Standards for Clinical Trials of FSMP" were revised, removing specific requirements for the number of subjects and trial duration, enhancing scientific rigor and practicality. |
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July 2024 |
Categorized registration management and promulgated three registration guidelines for foods for special medical purposes (FSMP), specifically targeting electrolyte formula foods, carbohydrate component formula foods, and protein component formula foods. |
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August 2024 |
Priority review and approval were implemented for rare diseases and new types of FSMP urgently needed in clinical settings. The review time was shortened from 60 working days to 30 working days, with prioritized on-site inspections and sampling tests to accelerate product launch. |
Out of the 207 rare diseases included in China's first and second lists of rare diseases, 32 require the use of FSMP. Of these, 18 rare diseases have a particularly urgent and critical need for FSMP. To address this, the government is taking steps to:
1. Expedite Import of Urgent Needs: Temporarily adjusting the application of relevant provisions in the "Food Safety Law" in Hainan Free Trade Port to allow temporary import of small quantities of urgently needed FSMP for rare diseases that have already been legally marketed abroad.
2. Streamline Approval Process: The State Administration for Market Regulation is drafting the "Work Procedures for Priority Review and Approval of FSMP Registration," which has been open for public consultation. The next step is to proceed according to the established procedures and release the guidelines as soon as possible.
In conclusion, China's FSMP market is experiencing rapid growth, with a growing number of approved products, diverse dosage forms, and a focus on specialized services for rare diseases and the elderly. The government's commitment to streamlining regulations, supporting domestic innovation, and prioritizing urgent needs is paving the way for a more accessible and robust FSMP market in China.
Reference: People's Daily's Latest Report on FSMP
