Category Archives: Shanghai

Shanghai Orders Procurement Suspension for Ganmao Qingre Tablets – Hebei Tangwei Product Halted from Midnight, 21 September

Shanghai, China – 20 Sep 2026 – The Shanghai Medical Insurance Centralized Bidding and Procurement Administration Office announced that, pursuant to relevant directives of the National Healthcare Security Administration, the procurement qualification of one drug product – Ganmao Qingre Tablets (film‑coated), manufactured by Hebei Tangwei Pharmaceutical Co., Ltd. – will be suspended from 00:00 on 21 September 2026. The notice was addressed to all medical institutions and drug manufacturers participating in the city’s centralized procurement platform.

Policy Snapshot

ItemDetail
AgencyShanghai Medical Insurance Centralized Bidding and Procurement Administration Office
AuthorityRelevant document(s) of the National Healthcare Security Administration (specific document reference not disclosed)
MeasureSuspension of procurement qualification
Product Affected1 – Ganmao Qingre Tablets (film‑coated)
ManufacturerHebei Tangwei Pharmaceutical Co., Ltd.
Effective Time00:00, 21 Sep 2026
Suspension DurationNot disclosed
Reason for SuspensionNot disclosed in the notice body
Notice Date20 Sep 2026

Product Under Suspension

Generic NameDosage FormSpecificationUnitManufacturer
Ganmao Qingre Tablets (traditional Chinese medicine cold‑relief formula)Film‑coated tablet0.55 g per tablet × 32 tablets/box, aluminum‑plastic blister packagingBoxHebei Tangwei Pharmaceutical Co., Ltd.

Compliance Notes

  • Scope of Impact: With procurement qualification suspended, the affected Ganmao Qingre Tablets SKU cannot be purchased through Shanghai’s centralized procurement platform by medical institutions from the effective time – though the notice does not specify whether existing contracts or in‑transit orders are affected.
  • National‑Level Origin: The suspension is executed on the basis of a national directive rather than a Shanghai‑initiated review, indicating the underlying compliance issue originated at the National Healthcare Security Administration level and may extend to other provinces as they implement the same document.
  • Manufacturer Exposure: For Hebei Tangwei Pharmaceutical, the loss of procurement eligibility in Shanghai – one of China’s highest‑value pharmaceutical markets – removes a key public‑channel revenue line for the product until qualification is restored.
  • Restoration Pathway: The notice does not disclose the suspension’s duration, the specific grounds, or the procedure for reinstatement; affected enterprises will need to engage with the issuing authorities for remediation and restoration requirements.

Market Impact & Outlook

  • Enforcement Signal: The swift, midnight‑effective implementation underscores the increasingly automated and directive‑driven nature of China’s drug procurement credit management, where national‑level determinations translate directly into provincial platform actions.
  • TCM Procurement Discipline: The targeted product is a traditional Chinese medicine cold‑relief formula, extending procurement‑compliance enforcement into the TCM segment alongside chemical drugs and biologics.
  • Cross‑Province Watch: Because the action stems from a national directive, distributors and manufacturers should monitor whether other provincial procurement platforms issue matching suspension notices for the same product – a common pattern under China’s nationwide price‑and‑credit linkage mechanisms.
  • Immediate Action for Medical Institutions: Shanghai hospitals and clinics should remove the suspended SKU from ordering workflows effective 21 September to avoid transaction failures and compliance exposure.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding the suspension of procurement qualification, potential restoration of trading eligibility, and related enforcement actions for Ganmao Qingre Tablets in Shanghai and other jurisdictions. Actual results may differ due to risks including undisclosed suspension grounds and duration, appeal or remediation outcomes, and subsequent policy actions by the National Healthcare Security Administration and the Shanghai Medical Insurance Centralized Bidding and Procurement Administration Office.-China Health Reform Pulse

Policy Source: https://www.smpaa.cn/xxgk/gggs/2026/09/20/24901.shtml

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

Shanghai, China – 02 Sep 2026 – The Shanghai Healthcare Security Administration and the Shanghai Municipal Health Commission have jointly issued the “Catalogue of Medical Consumables for Shanghai Medical Institutions’ Medical Insurance (2026 Edition)”, mandating that all catalogued consumables be procured through full‑volume online sunshine procurement and sold at zero margin, with reimbursement governed by a Class A / Class B classification – Class B items carrying a 20% upfront cash co‑payment by insured patients. The notice takes effect on 6 November 2026 and simultaneously abolishes Shanghai’s 2019 catalogue of separately chargeable single‑use medical devices.

Policy Milestone

ItemDetail
Issuing AgenciesShanghai Healthcare Security Administration; Shanghai Municipal Health Commission
DocumentCatalogue of Medical Consumables for Shanghai Medical Institutions’ Medical Insurance (2026 Edition) – issued 2 Sep 2026
Policy BasisNHSA and seven other departments’ Pilot Program for Deepening Medical Service Price Reform (Yi Bao Fa [2021] No. 41)
Catalogue StructureFormulated in units of the national medical insurance medical consumables classification; subject to dynamic adjustment
Procurement RuleCatalogued consumables: full‑volume online sunshine procurement + zero‑margin sales; compliance with municipal listing/price‑negotiation and insurance payment rules
Reimbursement ClassesClass A: paid per basic medical insurance rules. Class B: patient pays 20% cash upfront, remainder paid per basic medical insurance rules
Effective Date6 November 2026; prior inconsistent provisions superseded
Repealed DocumentNotice 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

Shanghai, China – 11 Sep 2026 – The National Joint Procurement Office of Organized Drug Volume‑Based Procurement (JPO) has issued an announcement launching a price confirmation process for subtypes of compound amino acid injections that did not secure selection in the 12th round of nationally organized volume‑based procurement (VBP). Qualifying manufacturers that accept prices at or below a benchmark set at 1.8× the highest selected price of the comparable specification of compound amino acid 18AA‑Ⅶ injection may obtain “deemed selection” status – without agreed procurement volumes – through a time‑limited online window closing 23 September 2026.

Procurement Milestone

ItemDetail
Issuing BodyNational Joint Procurement Office (JPO)
Announcement Date11 Sep 2026
Policy TypePrice confirmation for compound amino acid injection subtypes under the 12th national drug VBP
12th VBP TimelineProposed selection results 31 Jul 2026; official publication 6 Aug 2026; agreed‑volume allocation to medical institutions completed 7 Sep 2026
Price Benchmark1.8× 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 Window14 Sep 2026, 09:00 – 17 Sep 2026, 12:00 (material amendments until 17:00, 17 Sep)
Price Confirmation Window21 Sep 2026, 09:00 – 23 Sep 2026, 12:00; submitted prices are final and irrevocable; non‑submission equals waiver
PlatformNational 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