Category Archives: Central Gov.

China Issues National FSMP Guidelines for Hospital Formularies

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

China Primary-Care Pilot Reform Expands Access in Rural Mountain Counties

Beijing, Aug. 26, 2026 – China’s five-year pilot program for primary health care reform has delivered measurable improvements in rural and mountainous regions, with two national pilot zones reporting stronger specialist networks, faster emergency response, and better chronic-disease management, according to officials at a National Health Commission press conference today.

The Commission launched the “comprehensive pilot zones for primary health care” in 2021 to address infrastructure gaps, upgrade workforce capabilities, and test integrated service models. Beijing’s Miyun District and Sichuan’s Luxian County – both designated as national pilots – have introduced innovations in resource allocation, talent development, and medical-prevention integration, with results now showing in patient access and satisfaction.

Key Takeaways

AttributeDetail
EventNational Health Commission Press Conference
DateAugust 26, 2026
ThemeReform and Innovation in Primary Health Care Pilot Zones
Featured PilotsMiyun District (Beijing), Luxian County (Sichuan)
Key Focus AreasResource allocation, talent training, emergency networks, chronic-care integration
Notable Outcomes基层 visit share rising; emergency response times shortened; chronic mortality down 3.25 pp

Miyun: Mountainous Terrain, Targeted Investment

Miyun, Beijing’s only national primary-care pilot, treats the designation as “a heavy responsibility,” said Zhang Bo, the district’s deputy party secretary. The district party committee established a leading group headed by the party secretary, and health-system performance is now incorporated into the overall party-building assessment.

Fiscal commitment is substantial: health spending has exceeded 13% of the district’s general public budget for three consecutive years, supplemented by nearly CNY 200 million from Beijing municipality to renovate old clinics and acquire new equipment. Over the same period, Miyun recruited 14 senior physicians and 82 university-trained village doctors.

To serve its scattered mountain communities, the district built a sub-regional medical center in the northern mountains, upgrading CT and dialysis units and developing four specialty departments – pain, digestion, blood dialysis, and ophthalmology. In 2025, that center’s annual outpatient visits rose 7.4%. More than 50% of appointments at secondary and tertiary hospitals are now reserved for primary-care referrals, and all grassroots facilities have stroke and chest-pain treatment units. About 30 municipal-level experts rotate weekly to remote clinics via “Internet+ health village” programs.

Luxian: Countywide Network and Digital Dispatch

Sichuan’s Luxian County, a 2021 pilot, has focused on integrating county-township-village resources through a closely knit medical community led by the county people’s hospital, said Wang Bin, party secretary of the medical community. “We unified management, pushed experts down, and linked data up,” Wang said.

The county has dispatched 149 full-time rotational experts to grassroots clinics, set up 46 joint outpatient departments – including gynecology and traditional Chinese medicine – and helped township centers add two hemodialysis rooms and four new clinical departments. More than 60 new techniques, such as laparoscopic hernia repair, are now performed at lower-level facilities.

Digital tools are central: the medical community’s shared imaging, ECG, and ultrasound platforms process remote consultations in real time. To date, nearly 71,500 remote ECG diagnoses, about 60,000 remote imaging reads, and over 1,200 remote ultrasound guidance cases have been completed, enabling mutual recognition of test results across the county.

Emergency care has been overhauled with a proprietary “Huijitong” platform – a ride-hailing-style dispatch system that automatically alerts the nearest ambulance and emergency team when a village doctor makes a one-tap call. Vital signs are transmitted en route, allowing hospital specialists to prepare treatment plans before the patient arrives. Last September, a 42-year-old heart-attack patient in Chaohe Town received emergency care within 4 minutes, reached the county hospital in 29 minutes, and underwent interventional surgery 26 minutes later – a total of 75 minutes from symptom onset to reperfusion.

Chronic-Care Reform: Tiered Management for 200,000+ Patients

Luxian’s party secretary and county magistrate, Zhang Cheng, outlined a chronic-disease management model targeting five conditions – hypertension, diabetes, COPD, lumbar disc herniation, and new strokes within six months – plus locally prioritized additions. A tiered responsibility system assigns hospital directors to geographic areas, family doctors to villages, and specialists to specific diseases. Patients are color-coded red (high-risk), orange (medium), and green (low) for differentiated management.

All 20 township health centers now run integrated chronic-disease outpatient clinics. Since 2020, the county’s premature mortality rate from four major chronic diseases has dropped by 3.25 percentage points. Luxian has invested CNY 1.6 billion to build or renovate 18 medical institutions, adding 126,500 square meters of floor space, and CNY 9 million to equip secondary centers with CT, gastroscope, and automated biochemistry analyzers. A “CT exam within one hour” service circle is now in place.

Frontline Delivery: Faster Visits, Personalized Care

At the community level, Miyun’s Guoyuan Community Health Center serves 75,000 residents. Director Wang Mingfu said the center redesigned its floor plan, placing consultation rooms and lab tests on the same floor and installing self-service kiosks, cutting average visit time by about 30 minutes. It has opened specialty clinics for hypertension, diabetes, osteoporosis, and COPD, and added sleep and gastroenterology clinics with expert support. A “Talk with the Director” and QR-code feedback system helps resolve patient complaints quickly.

Guoyuan also runs a weight-management and sarcopenia-prevention program. Since April 2026, more than 200 overweight residents have received personalized diet-exercise plans using body-composition analysis. Over 2,000 seniors have been screened for sarcopenia; 63 high-risk individuals completed 12-week exercise interventions, with significant improvements in lower-limb strength and balance.

For rural doctors, a training partnership with Peking University First Hospital and Miyun District Hospital has upgraded skills. Wang Rui, a general practitioner at Gaoling Township center, said the six-month program helped her handle emergencies and manage diabetes – citing a 57-year-old asthma patient stabilized and transferred, and a 67-year-old diabetic whose HbA1c dropped from 9.5% to normal with remote insulin adjustment.

Market Impact Analysis

The pilot results carry implications beyond the two demonstration zones. Miyun’s model – combining fiscal prioritization, specialist rotations, and digital referral pathways – offers a template for other mountainous regions with dispersed populations. Luxian’s integrated medical community and automated emergency dispatch system address the perennial challenge of rural-urban service gaps, potentially influencing provincial-level policies across western China.

The chronic-disease management framework, with its color-coded patient stratification and “three packages, four integrations” structure, signals a policy shift from episodic treatment to population-based preventive care. This aligns with national priorities on healthy aging and non-communicable disease control, areas where primary care systems have historically been weak.

For pharmaceutical and medical device suppliers, the expanded specialty services at township centers – including dialysis, imaging, and surgical capabilities – suggest growing procurement demand at the county level. The emphasis on remote diagnostics and data sharing also points to sustained investment in health IT infrastructure.

Forward-Looking Statement

The National Health Commission said it will hold additional press conferences in other pilot zones to share further reform experiences. Industry analysts expect the Commission to distill best practices into national guidelines for primary-care system upgrades, potentially influencing the next five-year health plan.

Miyun and Luxian’s progress in raising grass-roots unit visit shares and reducing chronic mortality offers early evidence that targeted investment and integrated management can yield measurable returns. However, replicating these results across China’s vast and diverse rural landscape – with significant inter-provincial disparities in fiscal capacity and workforce density – remains a formidable challenge. The coming 12–18 months will show whether these pilot models can scale effectively beyond their current geographies.-China Health Reform Pulse

Policy Source: https://www.nhc.gov.cn/xcs/c100122/202608/d4910e8ac75a474e9c86e07732fe6ae0.shtml

China Clears 11 Innovative Medical Devices for Special Review Track

Beijing, Aug 25, 2026 — China’s Center for Medical Device Evaluation (CMDE) unveiled the 14th batch of innovative medical device special review applications for 2026, clearing 11 products for an expedited regulatory pathway spanning advanced oncology therapy, cardiovascular implants, and brain-computer interfaces.

Regulatory Snapshot

AttributeDetail
IssuerCenter for Medical Device Evaluation (CMDE), National Medical Products Administration
DocumentAnnouncement of Review Results for Special Review Applications of Innovative Medical Devices (No. 14, 2026)
Legal basisNMPA Announcement [2018] No. 83 (Special Review Procedure for Innovative Medical Devices)
Products cleared11
Public comment periodAug 25, 2026 – Sept 8, 2026
Contactgcdivision@cmde.org.cn

Products Entering Special Review

The 11 devices span therapeutic areas from oncology to neurology:

No.ProductApplicantCategory
1Disposable Steep-Pulse Ablation Electrode NeedleHunan Eweid Medical Device Co., Ltd.Tumor ablation
2Aortic Root PatchBeijing Balance Medical Technology Co., Ltd.Cardiovascular surgery
3Aortic Valve Replacement SystemShenzhen Jianxin Medical Technology Co., Ltd.Structural heart
4Boron Neutron Capture Therapy SystemHuapeng Boron Neutron Technology (Hangzhou) Co., Ltd.Radiation oncology
5Bioresorbable Left Atrial Appendage OccluderShanghai Shape Memory Alloy Material Co., Ltd.Interventional cardiology
6Artificial Corneal Endothelial Membrane PatchAiyan Medical Co., Ltd.Ophthalmology
7Implantable Brain-Computer Interface NeurostimulatorBeijing PINS Medical Equipment Co., Ltd.Neurology / neurotechnology
8Implantable Tibial Nerve Stimulation SystemHangzhou Shenluo Medical Technology Co., Ltd.Neuromodulation
9Human Circulating Tumor Molecular Residual Disease Detection Kit (CPA Sequencing)Guangzhou Burning Rock Medical Laboratory Co., Ltd.Oncology diagnostics
10Focused Ultrasound Neuromodulation DeviceChongqing Haifu Medical Technology Co., Ltd.Therapeutic ultrasound
11Absorbable Dural Sealant GlueShandong Junxiu Biotechnology Co., Ltd.Neurosurgery

Market Impact Analysis

The 14th batch highlights Beijing’s continued prioritization of high-risk, high-innovation devices that address unmet clinical needs. Notable entries include Huapeng Boron Neutron Technology’s boron neutron capture therapy (BNCT) system—a cutting-edge radiation modality for refractory cancers—and Beijing PINS Medical’s implantable brain-computer interface neurostimulator, reflecting China’s strategic push into neurotechnology and advanced neuromodulation.

Cardiovascular devices dominate the roster with three entries, including an aortic valve replacement system and a bioresorbable left atrial appendage occluder, signaling sustained investor and regulatory interest in structural heart interventions. The inclusion of an artificial corneal endothelial membrane patch and an absorbable dural sealant glue underscores expansion into specialized surgical niches with limited existing treatment options.

Burning Rock’s circulating tumor molecular residual disease (MRD) detection kit, using combined probe anchor polymerization sequencing, positions the company to compete in the rapidly growing minimal residual disease monitoring market, a segment increasingly valued for post-surgical cancer recurrence surveillance.

Regulatory Caveats

CMDE emphasized that the public announcement does not constitute formal admission into the special review procedure; final eligibility depends on conclusive review outcomes. Entry into the special review track does not equate to regulatory confirmation of safety or efficacy. Applicants must continue development and submit formal registration applications, which will be evaluated under early engagement, dedicated reviewer, and scientific review principles—without reduced standards or abbreviated procedures.

Forward-Looking Statement

Industry analysts expect the 11 devices to benefit from expedited CMDE review timelines, typically compressing standard approval cycles by 30% to 50% for innovative products. The batch’s diversity—from BNCT systems to brain-computer interfaces—suggests regulators are casting a wide net for breakthrough technologies rather than concentrating on a single therapeutic area. Companies with pipeline candidates in neuromodulation, advanced radiation therapy, and molecular diagnostics should view the special review pathway as increasingly accessible, though the caveat on unchanged evidentiary standards means clinical trial requirements remain rigorous. Final special review determinations are expected by late September 2026, barring substantive objections during the two-week comment window.-China Health Reform Pulse

Policy Source: https://www.cmde.org.cn/xwdt/zxyw/20260825110558111.html