Formula foods for special medical purposes (hereinafter referred to as “special medical foods”) refer to specially processed and formulated foods designed to meet the specific nutritional or dietary needs of individuals with restricted food intake, digestive or absorption disorders, metabolic disorders, or specific disease conditions. They play a significant role in the development of the health industry and the physical well-being of the general public.To implement the spirit of the Third Plenary Session of the 20th CPC Central Committee, promote the coordinated development and joint governance of healthcare, medical insurance, and pharmaceuticals, further facilitate the distribution of medical foods in medical institutions, strengthen the standardized management of medical foods in medical institutions, ensure food safety and the quality of nutritional management, and explore new application scenarios for these products, the following guidelines are hereby issued to promote the high-quality development of the medical food industry in Dongcheng District.
I. Improving the Management System for the Use of Medical Foods
(1) Establish a Cross-Departmental Collaboration Mechanism. Improve communication and coordination mechanisms regarding medical foods. Relevant departments shall closely coordinate and cooperate in accordance with their respective responsibilities to jointly guide the standardized management of medical foods in medical institutions. Strengthen interdepartmental collaboration and vertical coordination, explore innovative operational models and institutional designs for cross-departmental joint supervision, continuously enhance the management and operational standards of medical foods in medical institutions, maintain market order in the medical food sector, effectively safeguard the health rights and interests of the public, and continuously advance the development of the medical food industry.
(2) Further Strengthen Clinical Nutrition Work. Strengthen the development of clinical nutrition departments and clinical nutrition practices. Clinical nutrition departments in medical institutions shall organize and carry out nutritional screening and assessment in accordance with the *Specifications for Nutritional Screening and Assessment (Trial)*, standardize the management and use of medical foods, and fully leverage the important role of medical foods in improving treatment outcomes and promoting patient recovery.
(3) Improve the clinical nutrition management system. Medical institutions shall earnestly fulfill their primary responsibility for food safety. In accordance with relevant laws, regulations, and technical standards, they shall establish and improve management systems covering the evaluation of medical food suppliers, inspection of incoming goods, storage, records of sales and use, health management of staff, food safety self-inspections, and emergency response.Medical institutions are encouraged to further establish and improve clinical nutrition management organizations, with the Clinical Nutrition Department responsible for the daily management of clinical nutrition within the institution. They should formulate management systems for the selection, procurement, storage, and clinical application of medical foods, and enhance the level of clinical nutrition quality management by focusing on annual quality control improvement goals for the clinical nutrition specialty.
(4) Improve and strengthen information system development. Encourage medical institutions with clinical nutrition departments to integrate medical foods into their institutional information systems to achieve standardized management throughout the entire usage process.
(5) Advance pilot projects for standardized management of medical foods in healthcare institutions. Select 1–2 healthcare institutions to serve as pilot sites for standardized medical food management. Jointly guide these institutions in formulating pilot implementation plans to promote standardized management of medical foods. Use these pilots to establish benchmarks and play a leading示范 role. Timely summarize experiences and roll them out as appropriate to accelerate the progress of standardized medical food management across all healthcare institutions in the region.
II. Improve the Pricing and Fee Formation Mechanism for Medical Foods
(6) Carry out relevant work on information business coding. Medical institutions using temporary codes for medical foods for fee settlement must report to the medical insurance department in advance and maintain the information business codes properly. Medical institutions shall code and charge for medical foods that have been registered and approved to facilitate standardized management of fee-related processes such as procurement, warehousing, dispensing, and sales. Actively explore the inclusion of medical food-related expenses in supplemental commercial health insurance by commercial insurance companies.
(7) Establish a pricing mechanism for medical foods. Medical institutions should, based on the types and quantities required for clinical needs, engage in negotiated procurement with medical food manufacturers and distributors to select high-quality products at reasonable prices. At the same time, they should standardize the management of medical food billing and price disclosure, and explore pricing mechanisms suited to their specific circumstances to enhance the internal drivers for the smooth circulation and use of products;Manufacturers and distributors of medical foods shall rationalize their pricing mechanisms, scientifically formulate product pricing plans, and establish a rational pricing system across procurement platforms, medical institutions, physical stores, and online channels to lay a solid foundation for the smooth, multi-channel sales of products.
III. Strengthening the Regulatory Framework for Medical Food Operations
(8) Promote Food Business Licensing or Filing by Medical Institutions. Actively publicize and implement laws, regulations, and policy requirements regarding food business licensing and filing. Raise medical institutions’ legal awareness of the importance of operating food businesses in compliance with the law, and accelerate the process of medical institutions applying for food business licenses or filing as the primary entities.Strengthen training and guidance for staff in relevant departments specifically responsible for food operation licensing and filing. Streamline the application process for medical institutions to obtain food operation licenses or file notifications, explore the establishment of a green channel for administrative licensing approvals, and accelerate the speed of approval or filing. Provide policy guidance and point-to-point targeted assistance to key medical institutions, offering “one-on-one, point-to-point” coaching for their applications for special medical food operation qualifications.
(9) Strengthen supervision of medical institutions’ business operations. Enhance oversight of the quality and safety of medical institutions’ operations involving special medical foods; guide medical institutions to strengthen industry management; improve guidance on the use of special medical foods; actively implement credit-based supervision; and improve the joint disciplinary mechanism for dishonest conduct regarding illegal activities in the quality and safety of special medical foods and their usage.
IV. Promoting High-Quality Development of the Medical Food Industry
(10) Promote the standardization of medical foods. Strictly enforce quality certification for medical foods and encourage leading enterprises to develop higher-level industry standards; strengthen the promotion and implementation supervision of standards, guiding enterprises to strictly produce and operate in accordance with standards and standardize product labeling; enhance supervision of market circulation and severely crack down on illegal activities such as unlabeled, substandard, and false advertising. Through standardization efforts, elevate the overall quality level of the medical food industry and promote its healthy development.
(11) Increase support through industrial policies. Using the establishment of a national-level medical food laboratory as a catalyst, we will enhance the level of integrated development, create a circular industrial belt for the medical and health sector, and build an industrial environment capable of meeting the future needs of the medical food industry.Fully leverage the resource advantages of medical institutions and research institutes to establish a platform for hospital-enterprise collaboration. Support local enterprises in technological innovation, product R&D, project implementation, and the commercialization of research outcomes, providing policy support in accordance with laws and regulations to accelerate the formation of a cluster effect. Innovate by introducing a “green channel” for domestic and foreign R&D and business entities, offering full-process services and integrated policy support.
(12) Explore and expand product application scenarios. In addition to sales channels such as medical institutions and pharmaceutical retail enterprises, actively explore the promotion and use of medical foods among target populations.Promote the use of medical foods in new settings such as elderly care facilities, community health service centers, and tertiary medical institutions. Raise public awareness regarding the scientific rigor, safety, and strict standards of medical foods in areas such as formula registration, production conditions, and regulatory requirements. Encourage collaboration between elderly care facilities and medical institutions on nutritional support to enhance and meet the elderly population’s understanding of and demand for medical foods.We will promote the regularization of public education and outreach activities on nutrition and health to improve scientific understanding of medical foods, enhance and meet the nutritional and health needs of key populations, increase the accessibility of nutritional support provided by medical foods to the general public and key groups, and safeguard the health rights and interests of the people.
