Beijing, Aug. 26, 2026 – China’s National Health Commission and the State Administration for Market Regulation have jointly issued the first national guidelines governing the use of Foods for Special Medical Purposes (FSMP) in medical institutions, establishing a mandatory formulary system, standardized procurement and storage protocols, and dedicated sales areas, while giving local authorities flexibility to adapt implementation to regional conditions.

The Guiding Opinions on Standardizing the Use of Formula Foods for Special Medical Purposes in Medical Institutions, released following extensive research and provincial consultations, aim to advance clinical nutrition under the National Nutrition Plan (2017–2030) and strengthen patient nutritional support for those with restricted intake, metabolic disorders, or specific disease conditions.

Scope and Definitions

The guidelines apply to all types of medical institutions – defined as licensed diagnostic and treatment facilities – covering the entire lifecycle of FSMP within hospital premises: product selection, stocking, sale, and clinical use.

Core Provisions: Four Pillars

1. Establish a formulary and management mechanism. Each institution must designate a dedicated FSMP management department or team, create and dynamically maintain a FSMP Supply Catalog (limited to nationally registered products), and implement systematic procedures for selection, review, procurement, utilization tracking, periodic evaluation, and delisting.
2. Strengthen in-hospital controls across the supply chain. Institutions must enforce rigorous protocols for procurement (including incoming inspection and record‑keeping), warehousing, inventory management, sales, use tracking, and recall handling. Designated food safety personnel are required, and all physicians or clinical nutritionists involved in FSMP use must complete specialized training in clinical nutrition and FSMP management.
3. Standardize clinical workflow. Clinicians must prioritize dietary counseling first; FSMP may be recommended only when dietary intervention is insufficient, based on clear clinical indications. Informed consent must be obtained, with explicit disclosure of the product’s nutritional (non‑drug) nature and available alternatives. Inpatient FSMP use must be documented in medical records, with periodic reviews of appropriateness and rationality conducted by the hospital’s FSMP team.
4. Create independent, clearly marked sales areas. Institutions must establish designated FSMP sales zones or counters with conspicuous signage reading “Foods for Special Medical Purposes Sales Area (or Counter).” Sales records – including patient details, product specifications, and pricing – must be retained in alignment with medical record retention periods. Hospitals are also required to cooperate with manufacturers on product recalls by ceasing sales immediately and posting recall notices prominently.

Implementation and Regional Flexibility

The guidelines serve as a national framework, setting out core principles and common requirements. Recognizing significant inter‑provincial differences in economic development, healthcare resource availability, clinical nutrition capacity, and existing management practices, the document explicitly encourages local authorities to tailor implementation measures to their specific circumstances while adhering to the central tenets, ensuring effective and practical application to local clinical settings and patient needs.

Market Impact Analysis

The guidelines represent the first comprehensive national regulatory framework specifically addressing FSMP in clinical settings – closing a policy gap that previously left hospital use largely unregulated beyond general food safety and registration rules. For FSMP manufacturers, the mandatory formulary system reinforces the commercial value of national registration, as only registered products can secure a place on hospital catalogs. The requirement for dedicated sales areas and separate record‑keeping creates operational challenges for hospitals, necessitating investments in inventory systems, staff training, and IT integration to distinguish FSMP transactions from pharmaceutical and ordinary food channels.

The emphasis on clinical governance – including informed consent, medical record documentation, and periodic usage reviews – may temper utilization patterns, particularly for products with less robust evidence, while also protecting patients from inappropriate or coercive promotion. However, the guidelines remain silent on reimbursement and pricing, leaving cost‑related access issues to future policy evolution.

Forward-Looking Statement

The issuance of these guidelines signals the central government’s intent to formally integrate FSMP into the broader healthcare system, potentially paving the way for subsequent insurance coverage expansions and quality metrics. Provincial implementing rules are expected in the coming months, with pilot regions such as Sichuan – which already issued local FSMP management measures – likely to inform refinements. As China’s aging population and chronic disease burden grow, the formalization of FSMP as a regulated clinical tool may attract increased investment in product innovation and manufacturing capacity, particularly for condition‑specific formulations.-China Health Reform Pulse

Policy Source: https://www.nhc.gov.cn/sps/c100087/202608/342b9e4703d0465687d06e56de795311.shtml