Category Archives: Shanghai

Shanghai Publishes Medical Insurance Catalogue of Medical Consumables – Zero‑Margin Sales, Mandatory Sunshine Procurement and Class A/B Reimbursement From 6 November 2026

Policy Milestone

Item	Detail
Issuing Agencies	Shanghai Healthcare Security Administration; Shanghai Municipal Health Commission
Document	Catalogue of Medical Consumables for Shanghai Medical Institutions’ Medical Insurance (2026 Edition) – issued 2 Sep 2026
Policy Basis	NHSA and seven other departments’ Pilot Program for Deepening Medical Service Price Reform (Yi Bao Fa [2021] No. 41)
Catalogue Structure	Formulated in units of the national medical insurance medical consumables classification; subject to dynamic adjustment
Procurement Rule	Catalogued consumables: full‑volume online sunshine procurement + zero‑margin sales; compliance with municipal listing/price‑negotiation and insurance payment rules
Reimbursement Classes	Class A: paid per basic medical insurance rules. Class B: patient pays 20% cash upfront, remainder paid per basic medical insurance rules
Effective Date	6 November 2026; prior inconsistent provisions superseded
Repealed Document	Notice on Publishing the Catalogue of Single‑Use Medical Devices Eligible for Separate Charging (Hu Yi Bao Jia Cai [2019] No. 84)

Catalogue Framework & Billing Rules

Classification‑Based Design: The Shanghai catalogue is built unit‑by‑unit on the national medical insurance consumables classification system, ensuring alignment with national coding, and will be dynamically adjusted as the market and clinical practice evolve.
“Basic Consumables” Prohibition: When delivering care, medical institutions must provide consumables already included in the “basic consumables” component of medical service price items – they may not require patients to self‑procure such items or charge for them separately.
Sunshine Procurement & Zero Margin: All catalogued consumables must be purchased entirely online through transparent procurement channels and sold to patients at zero markup, following Shanghai’s rules on listing, price negotiation and insurance payment.
Class A/B Payment Mechanics: Class A consumables are reimbursed directly under Shanghai’s basic medical insurance regulations; Class B consumables require the insured patient to first bear 20% in cash, classified as a self‑pay share, with the remaining cost then reimbursed per standard rules.

Exemptions & Special Populations

Excluded Groups: The proportional Class B co‑payment rules apply to Shanghai basic medical insurance participants, except veteran Red Army soldiers, retired cadres and disabled veterans graded 1–6, who are exempt.
Mutual‑Aid Plan: Participants in the Shanghai Community Medical Mutual‑Aid Assistance Program follow the same rules by reference.
VBP Products: Payment methods for medical consumables covered by national, alliance‑level and Shanghai‑organized volume‑based procurement are governed by their respective existing regulations.

Market Impact & Outlook

End of Separate‑Charging Era for Listed Devices: Abolishing the 2019 separately chargeable single‑use device catalogue and replacing it with a unified insurance catalogue removes a legacy add‑on billing channel, tightening hospital revenue from consumables and shifting the margin burden entirely off patients for basic consumables.
Zero‑Margin Discipline: Mandatory zero‑margin sales plus full‑volume online sunshine procurement eliminate hospital mark‑up incentives on catalogued consumables, reinforcing the national “zero‑markup” consumables policy and pushing supplier competition onto listed prices.
Class B Co‑Pay Certainty: A uniform 20% upfront self‑pay ratio for Class B consumables gives manufacturers and hospitals a predictable reimbursement structure – but keeps cost‑sensitivity high for premium‑priced Class B products.
National Coding Convergence: Building the catalogue on the national classification deepens Shanghai’s alignment with NHSA‑led consumables governance, easing cross‑province comparability and future national catalogue integration.
Implementation Window: Hospitals and suppliers have roughly two months (to 6 November 2026) to remap billing systems, procurement workflows and product listings to the new catalogue.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding the implementation of the Shanghai medical insurance medical consumables catalogue, including procurement compliance, reimbursement operations and dynamic catalogue adjustments. Actual outcomes may differ due to risks including implementation execution by medical institutions, supplier listing and pricing adjustments, and subsequent policy updates by national or municipal authorities.-China Health Reform Pulse

Policy Source: https://ybj.sh.gov.cn/qtwj/20260911/ea41e7ead0ff4f60b191f07967d71a5f.html

Joint Procurement Office Opens Price Confirmation for Compound Amino Acid Injection Subtypes – “Deemed Selection” Route Added to China’s 12th National VBP Round

Procurement Milestone

Item	Detail
Issuing Body	National Joint Procurement Office (JPO)
Announcement Date	11 Sep 2026
Policy Type	Price confirmation for compound amino acid injection subtypes under the 12th national drug VBP
12th VBP Timeline	Proposed selection results 31 Jul 2026; official publication 6 Aug 2026; agreed‑volume allocation to medical institutions completed 7 Sep 2026
Price Benchmark	1.8× the highest selected price of the comparable specification of compound amino acid 18AA‑Ⅶ injection (incl. 18AA‑Ⅶ‑SF), adjusted for each subtype’s specification, usage volume and price‑comparison relationship
Registration Window	14 Sep 2026, 09:00 – 17 Sep 2026, 12:00 (material amendments until 17:00, 17 Sep)
Price Confirmation Window	21 Sep 2026, 09:00 – 23 Sep 2026, 12:00; submitted prices are final and irrevocable; non‑submission equals waiver
Platform	National Healthcare Security Service Platform (fuwu.nhsa.gov.cn), using 12th‑round VBP enterprise accounts

Price Confirmation Rules – “Deemed Selection” Conditions

A compound amino acid subtype is granted deemed selection (with no agreed procurement volume) only if all of the following are met simultaneously:

Benchmark Test: Accepted price does not exceed the applicable price‑comparison benchmark (anchored to 1.8× the highest selected price of 18AA‑Ⅶ).
Own‑Price Test: Accepted price does not exceed the manufacturer’s lowest national listed price for the same brand – excluding invalid listings such as “inactive zone” prices.
All‑Specifications Test: Where a manufacturer produces multiple specifications of the same subtype (differing in content, fill volume or packaging), every specification must participate and satisfy both tests above.
SF Equivalence: Specifications labeled “SF” and those without the SF designation are treated as the same subtype for price confirmation.
All‑or‑Nothing Discipline: If any single specification of a subtype fails the rules, or if a company selectively participates with only part of its specifications, the entire subtype is deemed waived.

Scope, Exclusions & Eligibility

Excluded Products: Compound amino acid 18AA‑Ⅶ injection itself (both selected and non‑selected in the 12th VBP); pediatric‑only subtypes (generic names marked “pediatric/children” or pediatric‑restricted labeling); products that are not reference‑listed preparations; and products that have not passed (or are not deemed to have passed) the generic quality and consistency evaluation (GQCE).
Eligibility: Enterprises must meet the declaration qualifications of the 12th VBP procurement document (GY‑YD2026‑1); products must hold a valid domestic registration approval obtained by 11 September 2026 (inclusive).
Submission Requirements: Registration materials (waived for subtypes already cleared in the 12th VBP registration phase), a price confirmation commitment letter, and each subtype/specification with its lowest national listed price backed by provincial platform screenshots. Where company‑submitted listing data conflicts with JPO verification, the JPO’s verified data prevails.

Compliance, Penalties & Market Consequences

Red/Yellow Label Relief: Products granted deemed selection are exempt from red/yellow price‑risk labeling; existing red or yellow marks will be revoked by provincial procurement platforms as listed prices are adjusted to the confirmed level.
Risk Labeling for the Rest: After price confirmation concludes, all non‑selected compound amino acid injection products – including 12th VBP non‑winners, non‑participants, and products ineligible for VBP or confirmation (GQCE‑excluded), but excluding pediatric subtypes – will be flagged red or yellow by JPO member units under listed‑price governance rules, warning hospitals of procurement risk.
Credit‑Based Revocation: Deemed selection is terminated if a company is rated “seriously dishonest” or “particularly seriously dishonest” under the drug price and procurement credit evaluation system for kickbacks, tax violations, monopoly distribution control or similar misconduct.
False‑Information Sanctions: Submitting falsified listing‑price information results in disqualification and potential placement on the “violation list.”
Supply Obligations: Deemed‑selected products must mirror selected‑drug requirements, including full traceability‑code upload, timely supply and guaranteed delivery.
No Late Additions: Subtypes that fail to obtain deemed selection receive no supplementation during the 12th VBP execution period; however, newly approved specifications accepting the rules may apply to the JPO for deemed‑selection status.

Market Impact & Outlook

Extended Price Discipline: The mechanism drags non‑selected compound amino acid subtypes toward the 1.8× benchmark, tightening the effective price ceiling across the entire amino acid injection category beyond the formally selected 18AA‑Ⅶ products.
Portfolio‑Level Bargaining: The all‑specifications, all‑or‑nothing rule forces manufacturers to align pricing across entire subtype portfolios, discouraging cherry‑picking and compressing arbitrage between specifications.
Label Arbitrage Ends: The red/yellow flagging of holdout products – combined with label removal for compliant ones – creates a direct commercial incentive for hospitals to avoid non‑confirmed products, effectively marginalizing price‑resistant brands.
Compressed Timeline: With registration closing 17 September and irreversible price submissions due 23 September, companies face a decision window of roughly two weeks to model pricing against both the benchmark and their own national lowest listed prices.
Awarded Prices: Subtype‑level benchmark values and the highest selected price of 18AA‑Ⅶ were not disclosed in the announcement.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding the price confirmation process, deemed‑selection outcomes, red/yellow labeling enforcement and supply compliance for compound amino acid injection subtypes under China’s 12th national volume‑based procurement. Actual results may differ due to risks including enterprise pricing decisions, JPO verification outcomes, credit‑rating actions, and subsequent policy adjustments by the National Healthcare Security Administration.-China Health Reform Pulse

Policy Source: https://www.smpaa.cn/gjsdcg/2026/09/11/24423.shtml

China Approves 13th Batch of National Drug Procurement Information Changes

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Beijing, Sept 4, 2026 — China’s National Drug Centralized Procurement Office approved the 13th batch of information changes for selected drugs under the national volume-based procurement program, allowing winning manufacturers to update marketing authorization holders, production sites, specifications, packaging, and corporate names without losing their selected status.

Policy Snapshot

Attribute	Detail
Issuer	National Drug Centralized Procurement Joint Office
Document	Notice on Information Changes of Selected Drugs in National Centralized Procurement (13th Batch)
Effective date	Sept 4, 2026
Scope	Selected drugs under national volume-based procurement
Permitted changes	Marketing authorization holder; manufacturer; specifications; packaging; corporate name
Condition	Selected enterprises must meet specified eligibility criteria
Action required	Information linkage updates; platform listing adjustments; procurement coordination

Key Provisions

Under the National Drug Centralized Procurement Document and related regulations, winning enterprises that satisfy defined conditions may modify critical product and corporate information while retaining their selected procurement qualification. The office verified enterprise application materials before granting approval for the 13th batch of changes. All relevant parties—including medical institutions, distributors, and procurement platforms—must promptly complete information synchronization, online listing updates, and purchasing workflow adjustments to reflect the revised drug details.

Market Impact Analysis

The 13th batch approval signals continued regulatory flexibility within China’s rigid national procurement framework, acknowledging that corporate restructuring, manufacturing consolidation, and product line optimization are inevitable in a market undergoing rapid consolidation. By allowing marketing authorization holder and production site transfers without stripping selected status, regulators are preventing supply disruptions that could arise if every corporate change triggered automatic re-tendering.

For pharmaceutical companies, the change mechanism provides a critical pathway to optimize manufacturing footprints and transfer assets between subsidiaries without sacrificing the hard-won volume commitments secured through national bidding. However, the requirement to meet unspecified “certain conditions” implies that not all change requests are automatically approved, creating a compliance gate that favors well-resourced enterprises capable of navigating administrative verification.

For hospitals and procurement platforms, the batch release demands immediate system updates to ensure that purchasing records, invoice matching, and inventory management align with the revised drug information. Failure to synchronize could result in settlement delays or compliance flags during audits.

Forward-Looking Statement

Industry analysts expect the national procurement office to maintain a regular cadence of information change approvals—likely quarterly or monthly—as the volume-based procurement program matures and corporate restructuring accelerates across the domestic pharmaceutical sector. The 13th batch suggests the approval pipeline is processing applications efficiently, with minimal backlog. Companies planning mergers, acquisitions, or manufacturing transfers for selected products should file change applications proactively, as the office’s willingness to approve such modifications reduces the regulatory risk traditionally associated with post-award corporate actions. The batch release also sets a template for provincial procurement alliances, many of which are expected to adopt similar change-management protocols to ensure supply continuity across decentralized procurement networks.-China Health Reform Pulse

Policy Source: https://www.smpaa.cn/gjsdcg/2026/09/04/24314.shtml