Beijing, Aug 6, 2026 — China’s National Health Commission and State Administration for Market Regulation jointly issued guidelines to standardize the use of foods for special medical purposes (FSMP) in medical institutions, requiring hospitals to establish dedicated management departments, segregated sales zones, and strict clinical protocols while explicitly banning the products from being treated as drugs or prescribed via standard prescriptions.
Policy Snapshot
| Attribute | Detail |
|---|---|
| Issuers | National Health Commission General Office; State Administration for Market Regulation General Office |
| Document | Guiding Opinions on Standardizing the Use of Formula Foods for Special Medical Purposes in Medical Institutions |
| File No. | Guo Wei Ban Shi Pin Fa〔2026〕No. 11 |
| Scope | All medical institutions holding a Medical Institution Practice License or clinic filing certificate |
| Target products | FSMP products registered with the national market regulator |
| Effective date | Aug 6, 2026 |
Key Provisions
- Institutional governance — Hospitals must establish dedicated FSMP management departments or working groups, create dynamic institutional supply catalogs limited to nationally registered products, and implement centralized procurement, review, and exit mechanisms.
- Clinical oversight — Only physicians or clinical nutrition technicians with specialized training may recommend FSMP use. Dietary counseling must be prioritized; FSMP is suggested only when dietary intervention proves insufficient. Patient or guardian consent is required, with full disclosure that the product is not a drug and whether alternatives exist.
- Documentation — FSMP usage during hospitalization must be recorded in patient medical records, with periodic institutional reviews of usage appropriateness and rationality.
- Dedicated sales zones — Hospitals must establish clearly marked “FSMP Sales Zone” areas, segregated from pharmaceuticals. Sales records—including patient information, product name, specification, and price—must be retained per medical record standards.
- Prohibitions — FSMP cannot be sold or used as unregistered products; hospitals cannot coerce or induce patients to purchase FSMP from designated sources. The products are explicitly not drugs and cannot be issued via prescription; distribution and billing must be separated from pharmaceutical workflows.
- Recall protocols — Hospitals must cooperate with manufacturers on recalls, immediately halting sales, sealing inventory, and posting prominent recall notices.
Market Impact Analysis
The guidelines create a comprehensive regulatory framework for a segment that has historically operated in a gray zone between food and pharmaceutical oversight. By mandating that only nationally registered FSMP products enter hospital supply chains, regulators are effectively culling unregistered or borderline nutritional products that have penetrated clinical settings through informal channels.
For FSMP manufacturers—particularly domestic firms with robust registration portfolios in infant formula, geriatric nutrition, and metabolic disorder segments—the rules legitimize hospital distribution while raising compliance barriers for unregistered competitors. The requirement for dedicated sales zones and separation from drug prescribing workflows may force hospitals to reconfigure pharmacy and nutrition departments, creating short-term operational disruption but long-term standardization.
The prohibition on prescription issuance and the mandate for informed consent shift clinical liability toward physicians and nutrition technicians, potentially increasing institutional exposure if usage documentation is incomplete. The billing separation requirement also complicates revenue recognition for hospitals that had previously bundled FSMP with pharmaceutical charges.
Forward-Looking Statement
Industry analysts expect provincial health commissions to issue localized implementation templates within 60 to 90 days, potentially adding province-specific training requirements for clinical nutrition technicians. The national FSMP registration backlog—already strained by post-2020 regulatory tightening—could face additional pressure as hospitals purge unregistered inventory and demand shifts toward compliant products. Companies with robust pipelines in disease-specific nutrition, including oncology support and diabetes management formulas, are positioned to capture market share as the hospital channel formalizes. The guidelines also set the stage for potential reimbursement negotiations, as standardized hospital use could eventually qualify FSMP for inclusion in basic medical insurance pilot programs, though no timeline has been announced.-China Health Reform Pulse
Policy Source: http://wjw.xinjiang.gov.cn/hfpc/zcwj4/202608/822374ba4e68488db6ff7052a272b5b5.shtml