NMPA and SAMR Discipline Body Hold Half‑Year Governance Meeting – Innovation Support for Drugs and Medical Devices Takes Center Stage

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Beijing, China – 15 Sep 2026 – The Party Group of the National Medical Products Administration (NMPA) and the Discipline Inspection and Supervision Group of the State Administration for Market Regulation (SAMR) convened their second‑half 2026 regular meeting on comprehensive strict Party governance, holding a dedicated session on supporting the development of innovative drugs and medical devices. Lin Guoyao, head of the SAMR‑stationed supervision group and SAMR Party Group member, and Huang Guo, SAMR Party Group member and NMPA Party Group Secretary and Administrator, attended and addressed the meeting.

Meeting Snapshot

ItemDetail
Date15 September 2026
Convening BodiesNMPA Party Group; Discipline Inspection and Supervision Group stationed at SAMR (CCDI/NSC)
FormatRegular half‑year consultation meeting on comprehensive strict Party governance
Core AgendaPolitical oversight plus dedicated consultation on supporting innovative drugs and medical devices
Key AttendeesLin Guoyao (SAMR supervision group head); Huang Guo (NMPA Party Group Secretary & Administrator); NMPA Party Group members Lei Ping, Yang Sheng, Wang Weidong; heads of relevant NMPA departments and directly affiliated units
Stated ResultsProgress report on H1 2026 consultation tasks; deployment of supervisory recommendations for H2

Supervisory Assessment – Lin Guoyao

  • Reform Track Record: The NMPA has deepened review and approval reform under the “Four Strictest” requirements — strictest standards, supervision, punishment, and accountability — driving year‑on‑year growth in approvals of innovative drugs and devices, described as an “acceleration” in promoting innovation, while acknowledging remaining shortcomings.
  • Execution Discipline: Strengthen organizational leadership and reform‑advancement mechanisms, with enhanced inspection, tracking, and accountability to implement reform tasks in detail.
  • Development–Safety Balance: Proactively empower innovative drug and device R&D while comprehensively upgrading drug safety regulatory capacity to detect and处置 risks early.
  • “Three‑Medical” Coordination: More actively integrate into the coordinated development and governance of healthcare, medical insurance, and pharmaceuticals, align regulation with clinical needs, and guide local coordination of reform measures.
  • Global Engagement: Deepen international regulatory cooperation and mutual recognition, assess industry trends precisely, and integrate further into global drug and device safety governance.
  • Regulatory Science & Talent: Promote deep integration of regulatory science with industrial development and implement the guidance on strengthening drug regulation talent work in the new era.

NMPA Deployment – Huang Guo

  • H1 Review: Reported progress on H1 2026 consultation tasks and the NMPA’s work supporting innovative development across drugs, medical devices, and cosmetics; deployed implementation of the supervision group’s recommendations.
  • “Service + Review & Approval” Mechanism: Refine the new service‑oriented approval mechanism to encourage pharmaceutical R&D innovation, advance cell and gene therapy drug development and new‑method research, and support high‑level self‑reliance in medical devices.
  • Lifecycle Regulation: Strengthen full‑lifecycle oversight — institutionalize drug safety risk consultation, intensify quality supervision of centrally procured (VBP) winning products, and enhance post‑market monitoring and evaluation of innovative products.
  • Modernization & AI: Advance modernization of drug regulation, deepen the application of artificial intelligence in regulatory work, intensify regulatory science research, and participate deeply in global drug safety governance.
  • Strict Governance: Compact political responsibility for Party administration, maintain a high‑pressure anti‑corruption posture, continue the “Qinglang Yaojian” (Clear and Bright Drug Regulation) special campaign, and improve constraints and supervision over the exercise of power.

Industry Impact & Outlook

  • Approval Momentum: The leadership’s framing — rising innovative drug and device approval counts attributed to sustained review‑reform “acceleration” — signals continuity of the pro‑innovation approval posture into H2 2026 and beyond.
  • Frontier Modalities: Explicit backing for cell and gene therapy development and device self‑reliance points to sustained policy support for advanced‑therapy sponsors and domestic device manufacturers.
  • VBP Quality Scrutiny: Heightened supervision of centrally procured winning products raises the compliance bar for manufacturers holding volume‑based procurement awards — quality performance will be watched as closely as price.
  • AI‑Enabled Regulation: Deepening AI application in regulatory work suggests evolving review workflows and data expectations for industry submissions.
  • Governance Overlay: The coupling of Party‑governance discipline with regulatory policy underscores that reform execution and anti‑corruption compliance remain central to the NMPA’s operating model.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding NMPA regulatory reform priorities, supervision of innovative drugs and medical devices, and governance initiatives for the second half of 2026. Actual implementation may differ based on policy decisions, supervisory review outcomes, and evolving regulatory practice.-China Health Reform Pulse

Policy Source: https://www.cmde.org.cn/xwdt/zxyw/20260916083706136.html

Hunan Health Commission Opens Public Consultation on Medical Disputes Draft Regulations – Comments Due 15 October 2026

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Changsha, China – 14 Sep 2026 – The Hunan Provincial Health Commission has published the “Hunan Province Medical Dispute Prevention and Handling Regulations (Draft Proposal)” for province‑wide public consultation, inviting feedback from all sectors of society by 15 October 2026 via letter, telephone, or email. The move advances scientific and democratic legislation, enhancing legislative transparency and quality at the provincial level.

Policy Snapshot

ItemDetail
Issuing AuthorityHunan Provincial Health Commission
InstrumentHunan Province Medical Dispute Prevention and Handling Regulations (Draft Proposal)
StagePublic consultation (solicitation of opinions)
Publication Date14 September 2026
Comment Deadline15 October 2026
Submission ChannelsLetter, telephone, or email
ContactZhou Yuting, Hunan Provincial Health Commission; Tel: +86‑731‑8482‑2294
Mailing AddressNo. 30 Xiangya Road, Kaifu District, Changsha, Hunan 410000, China
Emailhnswjwfgc@163.com

Draft Framework & Legislative Context

  • Scope: As indicated by its title, the draft ordinance addresses both the prevention and the handling of medical disputes across Hunan Province. The full text is contained in the attached draft document (.docx) published alongside the notice; specific provisions were not detailed in the announcement itself.
  • Legislative Purpose: The commission states the consultation implements the principles of scientific legislation and democratic legislation, aiming to strengthen transparency and improve legislative quality.
  • National Alignment: Provincial regulations of this kind typically operationalize China’s national framework for medical dispute prevention and handling, extending State Council‑level rules into provincial administration — harmonizing hospital governance, dispute resolution channels, and liability handling within the local healthcare system.
  • Stakeholder Reach: The open call targets all sectors of society, including medical institutions, healthcare workers, patients and their representatives, legal professionals, and academic researchers.

Consultation Process & How to Comment

  • Channels: Comments may be submitted by postal letter, telephone, or email; no online portal was specified in the notice.
  • Deadline: All feedback must reach the commission by 15 October 2026.
  • Contact Point: Zhou Yuting, Hunan Provincial Health Commission — Tel: +86‑731‑8482‑2294; Email: hnswjwfgc@163.com; Address: No. 30 Xiangya Road, Kaifu District, Changsha (Postal Code 410000).

Policy Impact & Outlook

  • Healthcare Governance: A dedicated provincial ordinance would give Hunan’s health authorities a codified framework for defusing doctor–patient conflicts, potentially standardizing complaint intake, mediation pathways, and on‑site incident response in hospitals.
  • Risk Management for Providers: Medical institutions operating in Hunan should monitor the draft’s final provisions — dispute‑prevention obligations and handling procedures will likely translate into compliance requirements for hospital administration and clinical risk management.
  • Legislative Timeline: Following the consultation window, the commission will revise the draft based on public input before further legislative review; the timing of formal promulgation was not disclosed in the notice.
  • Signal to Peers: Provincial‑level codification of medical dispute rules continues a broader trend in China’s health governance, with Hunan joining other provinces in localizing the national dispute‑resolution regime.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding the legislative process for the Hunan Province Medical Dispute Prevention and Handling Regulations. The draft may be substantially revised following public consultation; final provisions, adoption timing, and implementation requirements remain subject to decisions by the Hunan Provincial Health Commission and the provincial legislature.-China Health Reform Pulse

Policy Source: http://wjw.hunan.gov.cn/wjw/xxgk/tzgg/202609/t20260915_34064527.html

Sichuan Drug Regulator Opens Call for TCM Standards Drafting Units – First Batch Covers New and Revised Herbal Material and Decoction Piece Monographs

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Chengdu, China – 15 Sep 2026 – The Office of the Sichuan Provincial Drug Administration (Sichuan MPA) has issued a province‑wide notice soliciting drafting units for the first batch of new and revised traditional Chinese medicine (TCM) standards, formally launching the revision cycle for the Sichuan Provincial Standards for TCM Materials (2010 Edition) and the Sichuan Provincial Processing Norms for TCM Decoction Pieces (2015 Edition). The call is open to drug testing institutions, universities and research institutes, and TCM production and R&D enterprises, with applications due by 8 October 2026.

Policy Snapshot

ItemDetail
Issuing AuthorityOffice of the Sichuan Provincial Drug Administration
InitiativeFirst batch of newly added and revised provincial TCM standards
Standards Under RevisionSichuan Provincial Standards for TCM Materials (2010 Edition); Sichuan Provincial Processing Norms for TCM Decoction Pieces (2015 Edition)
ScopeVarieties listed in Attachment 1 (new additions) and Attachment 2 (revisions); number of varieties not disclosed in the notice body
Eligible ApplicantsIndependently incorporated drug testing institutions, universities, research institutes, and TCM production/R&D enterprises
Submission Deadline8 October 2026 (based on time of receipt)
Funding ModelPrimarily self‑funded by drafting units; special subsidies or rewards‑in‑lieu‑of‑subsidies may be sought for annual key varieties that pass review
ContactsZhao Weiquan, Sichuan MPA, +86‑28‑8678‑6031; Qing Yan, Sichuan Institute for Drug Control, +86‑28‑8175‑4502

Scope of Work

  • Newly Added Varieties: Drafting units will conduct full quality‑standard research — literature verification, source origin, description, identification, checks, extractables, and content determination — and deliver a draft standard with drafting notes. Applications for new materials (including new botanical origins or new medicinal parts) must include origin verification, resource legality, safety, and clinical/medicinal evidence.
  • Revised Varieties: Units will perform verification research targeting the specific deficiencies identified in the catalogue (e.g., missing or outdated identification methods, unreasonable ash and extractable limits, inapplicable content‑determination methods), and may propose revisions beyond the listed issues.
  • Pharmacopoeia Alignment: Revisions must in principle be harmonized with the Chinese Pharmacopoeia 2025 Edition. Where Sichuan‑specific resources, clinical practice, or historical processing traditions justify divergence, applicants must submit comparative study data and rationale for expert panel adjudication.
  • Decoction Pieces Gap‑Filling: For decoction pieces lacking a corresponding material standard, the notice requires either establishing the material standard first or applying through an integrated material–decoction piece package, which is explicitly encouraged.

Eligibility & Selection Process

  • Qualifications: Applicants must hold independent legal‑person status with laboratory conditions, instrumentation, and technical staff adequate for TCM standards research; prior experience drafting or verifying national or provincial drug standards is a priority factor.
  • Integrity Requirement: No major drug quality/safety incidents or research misconduct records in the past three years.
  • Application Flexibility: One unit may apply for multiple varieties; multiple units may jointly apply for a single variety with a designated lead; applications for specific processing specifications within a multi‑specification variety are permitted.
  • Review Pathway: The Sichuan Institute for Drug Control will organize formal review, expert evaluation, and on‑site defense, then recommend a candidate list for Sichuan MPA approval and public announcement.
  • Submission: Two stamped paper copies to the Sichuan Institute for Drug Control (No. 8 Xinwen Road, Hi‑Tech Zone West, Pidu District, Chengdu), plus scanned and editable Word versions to zbbmsc@scidc.org.cn with the subject line “TCM Standards Drafting Unit Application + Unit Name.”

Industry Impact & Outlook

  • Standards Modernization: Upgrading monographs dating to 2010 and 2015 to align with the Chinese Pharmacopoeia 2025 Edition will reset quality benchmarks for TCM materials and decoction pieces produced and circulated in Sichuan, one of China’s key TCM resource provinces.
  • Strategic Opportunity: Participation gives testing institutions, academia, and TCM manufacturers direct influence over standard‑setting — positioning early entrants ahead of the compliance requirements that follow final adoption.
  • Funding Watch: Research funding remains largely self‑raised; the bureau’s pledge to pursue special subsidies for prioritized varieties could tilt participation toward larger, better‑resourced institutions.
  • Unclaimed Varieties: For varieties attracting no qualified applicants, the Sichuan MPA will make separate arrangements, leaving open the possibility of direct commissioning.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding the selection of drafting units, the timeline for standard revision and promulgation, and potential funding support. Actual outcomes may differ due to expert review results, application volume, and final regulatory decisions by the Sichuan Provincial Drug Administration.-China Health Reform Pulse

Policy Source: http://yjj.sc.gov.cn/scyjj/gztz/2026/9/15/1d68c0260a94442cb77c1a3fdab01504.shtml