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China Tightens Medical Device Quality Oversight: 2025 Inspection Plan Unveiled
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China’s National Medical Products Administration (NMPA) has released its 2025 medical device inspection plan, outlining stricter quality oversight and compliance requirements. The new guidelines aim to enhance product safety, enforce regulatory standards, and streamline market access for domestic and international manufacturers. Key Policy Highlights Impact on Medical Device Manufacturers Reinspection…
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Policy Analysis: Shanghai’s 2025 Pharmaceutical Procurement Regulation and Market Implications
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Shanghai’s Medical Centralized Bidding and Procurement Affairs Management Office has released its January 2025 list of monitored pharmaceutical varieties under the public tendering and price negotiation framework. The policy, outlined in Document No. 104 of 2023, emphasizes transparency, fairness, and price rationality in inter-provincial drug procurement. This regulatory move underscores…
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Guangdong Accelerates Centralized Procurement for Apixaban and Key Therapeutics
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The Guangdong Drug Trading Center has issued a critical update on preparations for the centralized volume-based procurement (VBP) of Apixaban Tablets and related medications under the Guangdong Alliance framework. This initiative, aligned with provincial healthcare policies (Yue Medical Insurance Letter [2025] No. 49), mandates streamlined logistics and supply chain coordination…
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China Unveils 2025 Medical Device Inspection Strategy to Tighten Quality Control
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China’s National Medical Products Administration (NMPA) convened a pivotal conference in Chengdu on March 24 to outline its 2025 medical device inspection agenda. The meeting highlighted achievements from 2024, including enhanced product quality and public safety, while emphasizing stricter compliance frameworks to address evolving industry risks. 2024 Progress and 2025…
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Shanghai Designates Backup Suppliers and Specialized Drug Formulations in GY-YD2024-2 Procurement
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Shanghai has finalized its list of second-tier backup suppliers and manufacturers for specialized drug formulations under the 10th National VBP (Volume-Based Procurement) Program (GY-YD2024-2). The move aims to stabilize supply chains, address market shortages of irregular drug specifications, and ensure cost-effective access to critical medications. Key suppliers include domestic pharmaceutical…
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China’s 2025 Pharmacopoeia Edition Approved, Set for October 1 Implementation
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The Pharmacopoeia of the People’s Republic of China (2025 Edition), released by the National Medical Products Administration and National Health Commission, has been approved by the 12th Conference of the Chinese Pharmacopoeia Commission (ChPC) Executive Committee. The new edition is scheduled for implementation on October 1, 2025. Regulatory RequirementsFrom the…
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China’s NHSA Releases 2024 Healthcare Security Bulletin Highlighting Insurance Coverage and Reimbursement
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China’s National Healthcare Security Administration (NHSA) has released its 2024 “Healthcare Security Development Statistical Bulletin.” The report reveals that by the end of 2024, over 1.33 billion people were enrolled in Basic Medical Insurance (BMI) schemes, maintaining a coverage rate of over 95%. Maternity insurance participation reached 252.98 million, an…
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NMPA Updates Rules on Domestic Production of Imported Medical Devices
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The National Medical Products Administration (NMPA) has released a notification on further adjusting and optimizing matters relating to the domestic production of imported medical devices by companies within China, effective immediately. This update aims to streamline the regulatory process and support the localization of production for imported medical devices. Key…
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Driving Innovation in Traditional Chinese Medicine: A Policy-Backed Renaissance
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In Depth Analysis of Policy News in the Pharmaceutical Sector: A Comprehensive Guide to the Development and Industry Growth of Traditional Chinese Medicine New Drugs. 1. Rising Trends in Traditional Chinese Medicine New Drug Approval and Market Expansion The past year has witnessed a significant uptake in the approval of…
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CDE Announces 92nd Batch of Reference Preparations for Generic Drug Evaluation
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China’s Center for Drug Evaluation (CDE) has released the 92nd batch of reference preparations for generic quality and consistency evaluation (GQCE). This initiative is part of the ongoing efforts to ensure the quality and consistency of generic drugs in the market. New AdditionsThe latest batch includes 33 new drugs and…
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CDE’s 2024 Annual Drug Review Report Shows Continued Growth in Regulatory Filings
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The Center for Drug Evaluation (CDE) released its 2024 annual drug review report, highlighting continued growth in drug regulatory filings. The CDE accepted a total of 19,563 filings of various types, marking a 5.73% year-on-year increase. Filings BreakdownThe filings included 17,476 for drug preparations, up 3.42% YOY, and 2,087 for…
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HMZS Biopharmaceutical Blacklisted After Failing to Monitor Production Process
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HMZS Biopharmaceutical, a Chinese company that won a bid for its phloroglucinol in the 10th volume-based procurement (VBP) tender round, has been blacklisted by the National Drug Alliance Procurement Office. The company’s entrusted manufacturer, Taiji Group Sichuan Taiji Pharmaceutical Co. Ltd., was also blacklisted following the incident. Reason for BlacklistingThe…
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China Issues Guidelines for Informatization of Compact County-level Medical Communities
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The National Health Commission (NHC), National Administration of Traditional Chinese Medicine, and National Disease Control and Prevention Administration jointly released a notification to guide the informatization function of compact county-level medical communities. This initiative aims to enhance healthcare service integration and efficiency at the county level through advanced information technology.…
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CDE Releases 91st Batch of Reference Preparations for Generic Drug Evaluation
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China’s Center for Drug Evaluation (CDE) has released the 91st batch of reference preparations for generic drug quality and consistency evaluation (GQCE). This update is part of the ongoing efforts to standardize and improve the quality of generic drugs in the country. New Additions and RejectionsThe latest batch includes 59…
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China’s NHSA Issues Guidelines for Neurological Medical Services Pricing
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China’s National Healthcare Security Administration (NHSA) has released the “Guidelines for the Pricing Project Initiation for Neurological Medical Services (Trial)”, aimed at guiding provincial healthcare security administration bureaus to formulate unified provincial price benchmarks. This initiative integrates the current pricing items for the nervous system into 82 items, including 24…
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Major Policy Directions in China’s Healthcare Arena: A Comprehensive Breakdown
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In a momentous address at the Third Session of the 14th National People’s Congress on March 5, Chinese Premier Li Qiang presented the Government Work Report, offering profound insights into the country’s healthcare policy direction. This report not only underscores the government’s commitment to public welfare but also charts a…
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CDE Launches SPARK Project to Boost Pediatric Antitumor Drug R&D
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China’s Center for Drug Evaluation (CDE) has released a notification to solicit feedback on its Support Anti-tumor drugs R&D for Kids (SPARK) project within one month. This initiative marks a significant step forward in promoting the development of pediatric antitumor drugs. Project BackgroundThe SPARK project is a pilot effort in…
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National Allied Procurement Office Allows VBP Winners to Adjust MAH and Manufacturing Details
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The National Allied Procurement Office has issued a notification clarifying rules for China’s Volume-Based Procurement (VBP) tender program, allowing winning manufacturers to modify key details such as the marketing authorization holder (MAH), manufacturing company, packaging specs, and supply arrangements under specific conditions. The changes aim to maintain supply stability while…
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AI in Healthcare: The Impact of DeepSeek Technology and Industry Developments
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The integration of advanced AI technologies into healthcare is revolutionizing the industry, and the recent developments involving DeepSeek technology have further amplified this transformation. As highlighted by policy updates and industry trends, AI-powered solutions are gaining momentum across various sectors of healthcare, from diagnostics to drug discovery. This article explores…
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In-Depth Analysis of the National Healthcare Security Policy: A Guide to Key Reforms and Implications
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The National Healthcare Security Administration (NHSA) has unveiled its 2025 priority action list, focusing on improving efficiency and accessibility in healthcare services. This policy reform targets three key stakeholders: designated medical institutions, pharmaceutical companies, and insured individuals, introducing six major service initiatives. Below is a detailed analysis of the reforms,…
