Two Departments Jointly Issue Guiding Opinions to Regulate the Use of Foods for Special Medical Purposes by Medical Institutions
两部门联合出台指导意见 规范医疗机构使用特殊医学用途配方食品
To implement the relevant requirements of the clinical nutrition action under the National Nutrition Plan (2017–2030), and to guide and regulate the clinical use of foods for special medical purposes (hereinafter referred to as FSMP), the National Health Commission and the State Administration for Market Regulation recently jointly issued the Guiding Opinions on Regulating the Use of Foods for Special Medical…
Standards & regulationEU industry & firmsMixedMaterialStructural shift
The mechanism
Chinese hospitals are required to create FSMP supply catalogues and controls covering procurement, storage, sale, use and recall. They also need lawful, standardised sourcing, designated sales points and retained sales data. This raises onboarding and documentation demands for EU clinical-nutrition suppliers selling through Chinese medical institutions, assuming their products are already registered for China’s domestic market. It may also make hospital purchasing more legible for suppliers able to meet the controls.
The stakes
If implemented consistently, the guidance makes compliance systems part of access to China’s clinical-nutrition channel rather than a peripheral distributor issue. Its effect would be far smaller if hospitals treat it as a codification of existing practice and enforce it unevenly.
How it reaches Europe
- Joint guidance is issuedThe National Health Commission and market regulator jointly set requirements for medical institutions’ FSMP use.
- Hospitals build FSMP cataloguesThe guidance requires supply catalogues and management systems across receipt, use and charging.
- Purchasing becomes more controlledProcurement, storage, sale, use and recall are specified as in-hospital management stages.
- EU suppliers face documented onboardingAssuming they sell into Chinese hospitals, lawful sourcing and retained sales information become purchasing conditions.