Category Archives: Central Gov.

China Backs Centralized Production of Hospital Preparations in TCM

Beijing, Aug 14, 2026 — China’s National Medical Products Administration (NMPA) endorsed centralized manufacturing models for hospital traditional Chinese medicine (TCM) preparations in an official reply to a National People’s Congress proposal, outlining a regulatory framework that shifts traditional formulas toward regional production hubs while tightening quality controls and streamlining filing requirements.

Policy Snapshot

Attribute	Detail
Document	Reply to Proposal No. 3936, 14th NPC 4th Session
Proposer	Deputy Fan Zhen
Issuers	NMPA; National Administration of Traditional Chinese Medicine
Key regulation	Revised Drug Administration Law Implementing Regulations (effective May 15, 2026)
Core focus	Hospital preparations; centralized production; regional formulation centers

Regulatory Streamlining

The NMPA highlighted that the revised Drug Administration Law Implementing Regulations, effective May 15, 2026, codify simplified pathways for hospital TCM preparations. Institutions using traditional preparation methods need only file with provincial regulators rather than seek full approval. Formulations with a five-year or longer clinical use history within the same hospital are exempt from pharmacodynamics and single- and repeat-dose toxicity studies.

The agency also clarified that outsourcing preparation no longer requires a separate regulatory license; hospitals need only file with provincial authorities as the delegating party. The rules mandate that hospital legal representatives and primary executives bear full responsibility for formulation quality, and require provincial regulators to decide on inter-hospital transfer applications within five working days.

The NMPA pointed to its 2023 measures on TCM scientific supervision, which encourage hospitals to use big data, artificial intelligence, and real-world evidence to study clinical positioning, target populations, and dosage regimens for institutional preparations. The framework explicitly supports converting proven hospital formulations with distinct advantages and low adverse-event profiles into new drug candidates.

Quality Safeguards

Regulators pledged intensified inspections of preparation and use processes, with particular scrutiny on outsourced manufacturing by small TCM clinics. The NMPA urged hospitals to establish pharmacovigilance systems for adverse reaction monitoring and endorsed multi-center clinical studies through inter-hospital transfers. The framework requires full traceability of raw materials, production controls, and quality testing.

Centralized Production Push

In the most significant policy signal, the NMPA and NATCM endorsed piloting regional formulation centers to enable shared production, unified quality control, and consolidated distribution of hospital TCM preparations. The agencies said they would draw on national drug traceability system experience to explore full-process digital tracking for institutional formulations, and will summarize local pilot experiences to refine centralized manufacturing and transfer policies.

Market Impact Analysis

The endorsement of regional formulation centers marks a structural shift for China’s hospital TCM sector, which has historically relied on fragmented in-house preparation labs. Centralized production could reduce per-unit manufacturing costs and standardize quality across institutions, but may force smaller hospitals to abandon independent formulation capabilities and rely on regional hubs.

The exemption of five-year traditional formulas from toxicity studies lowers the barrier for heritage formulations to achieve regulatory status, potentially accelerating the pipeline of hospital-developed drugs toward new drug conversion—a pathway the NMPA explicitly supports. For pharmaceutical contract manufacturers, the regional hub model creates new partnership opportunities with hospital networks, particularly in provinces with dense TCM institution clusters.

Forward-Looking Statement

Industry analysts expect the NMPA to release detailed regional formulation center guidelines within 12 to 18 months, following pilot program evaluations. The convergence of simplified filing rules, digital traceability mandates, and centralized production incentives suggests Beijing is positioning hospital TCM preparations as a controlled but strategically important bridge between traditional practice and modern pharmaceutical manufacturing. Companies with expertise in TCM formulation technology and pharmaceutical logistics are likely to benefit as provincial governments begin tendering regional hub contracts in late 2026 and 2027.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/zwgk/jyta/rdjy/20260825155646136.html

China Suspends Avinger Medical Devices Over Failed Inspection

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Beijing, Aug 25, 2026 — China’s National Medical Products Administration (NMPA) suspended the import, sale, and use of three medical devices from U.S.-based Avinger, Inc. after the company failed to submit required documentation for an overseas inspection, marking a rare enforcement action against a foreign manufacturer for procedural non-compliance.

Regulatory Snapshot

Attribute	Detail
Issuer	National Medical Products Administration (NMPA)
Announcement	2026 No. 80
Target company	Avinger, Inc. (United States)
Effective date	Aug 25, 2026
Legal basis	Provisions for Overseas Inspections of Drugs and Medical Devices, Article 28; Medical Device Supervision and Administration Regulations
Violation	Failure to submit power of attorney, product information forms, and site master files within required timeframe
Finding	Non-compliance with China’s Medical Device Production Quality Management Specification (GMP)

Affected Products

Product	Registration No.	Description
Pantheris Catheter	国械注进20263010082	Single-use peripheral vascular plaque resection catheter
Pantheris SV Catheter	国械注进20253010610	Single-use peripheral vascular plaque resection catheter
Lightbox 3 OCT Imaging Console	国械注进20263010131	Intravascular optical coherence tomography and power control device

Enforcement Rationale

Under the NMPA’s 2026 overseas inspection plan, regulators scheduled an on-site review of Avinger’s manufacturing and quality systems. Avinger did not provide the mandated authorization letter, product status documentation, or site master file within the stipulated deadline. Pursuant to Article 28 of the overseas inspection regulations, the NMPA classified the deficiency as a failure to meet China’s medical device GMP standards, triggering an immediate suspension of all commercial activities for the three registered products.

Market Impact Analysis

The suspension halts Avinger’s commercial access to China’s market for its peripheral vascular and intravascular imaging portfolio. The Pantheris catheter line, used in peripheral artery disease interventions, and the Lightbox 3 OCT console, used for real-time intravascular imaging, are now barred from importation, distribution, and clinical use nationwide. For Chinese hospitals and distributors, the ban creates an immediate supply gap in peripheral atherectomy and OCT-guided vascular procedures, potentially shifting demand to competing devices from domestic or other international manufacturers.

The enforcement signals heightened NMPA willingness to invoke suspension powers for procedural lapses, not just product quality failures. By acting on documentation deficiencies rather than clinical adverse events, regulators are raising the compliance bar for foreign manufacturers navigating China’s overseas inspection regime.

Forward-Looking Statement

Industry analysts expect Avinger to face a lengthy reinstatement process requiring full documentation submission, followed by a rescheduled inspection and potential corrective action verification. The case is likely to prompt other U.S. and European device makers to audit their China regulatory file readiness, particularly authorization letters and site master files, ahead of scheduled 2026 overseas inspections. With Beijing intensifying scrutiny of imported medical devices, manufacturers with pending NMPA registrations should treat documentation compliance as a critical path item to avoid similar market access disruptions.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/ylqx/ylqxggtg/20260825165610199.html

China Seeks Input on Drug QTc Clinical Trial Guidelines

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Beijing, Aug 26, 2026 — China’s Center for Drug Evaluation (CDE) released draft technical guidelines for clinical research on drug concentration-QTc (C-QTc) relationships, opening a one-month public comment period to standardize cardiac safety assessments for innovative medicines.

Regulatory Snapshot

Attribute	Detail
Issuer	Center for Drug Evaluation (CDE), National Medical Products Administration
Document	Draft Technical Guidelines for Clinical Research of Drug Concentration QTc
Scope	C-QTc clinical studies and data analysis for cardiac safety evaluation
Target drugs	Innovative medicines requiring cardiac safety profiling
Comment deadline	One month from publication
Contacts	Wang Yuzhu (wangyzh@cde.org.cn); Ma Jingyi (majy@cde.org.cn)

Technical Context

The draft guidelines address concentration-QTc (C-QTc) modeling, a statistical approach used to evaluate whether a drug prolongs the corrected QT interval in an exposure-dependent manner. C-QTc analysis is increasingly favored as an alternative or complement to traditional thorough QT (TQT) studies under ICH E14 frameworks, allowing sponsors to integrate cardiac safety assessment into early-phase trials rather than conducting standalone studies.

Market Impact Analysis

The guideline marks a significant step in aligning China’s cardiac safety evaluation standards with international ICH E14 Q&A updates. For pharmaceutical developers, particularly those in oncology, central nervous system, and infectious disease pipelines where QT prolongation is a known class risk, the document provides a regulatory pathway to use C-QTc modeling as primary evidence for QT liability assessment. This could reduce clinical development timelines and costs by eliminating the need for separate TQT studies when robust exposure-response data is available.

The one-month comment window suggests CDE is moving quickly to finalize the guidance, reflecting urgency to keep pace with global regulatory convergence on cardiac safety methodologies. Domestic and multinational sponsors with pending new drug applications in China should review the draft closely, as the final version is likely to influence trial design for Phase I and Phase II studies currently in planning.

Forward-Looking Statement

Industry experts expect the finalized guidelines to be published by late 2026 or early 2027, following the comment period and potential revision. The adoption of C-QTc-centric guidance positions China to accept modeling-based cardiac safety waivers more routinely, potentially accelerating approvals for drugs in therapeutic areas where QT effects have historically triggered regulatory delays. Companies are advised to prepare C-QTc analysis capabilities—either internally or through specialized biostatistics contract research organizations—to align with the forthcoming mandatory standards.-China Health Reform Pulse

Policy Source: https://www.cde.org.cn/main/news/viewInfoCommon/77085aae69c2d59b829839cf7377f107