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Policy Analysis and Guidance: Guangdong Province’s Ninth Batch of National Centralized Drug Procurement Renewal

Guangdong Province’s Drug Exchange Center has issued a notice regarding the renewal of the ninth batch of national centralized drug procurement for the second procurement year, effective from March 30, 2025, to March 29, 2026. This policy aims to ensure the continuity of drug supply, maintain quality standards, and streamline procurement processes across healthcare institutions.

Key Policy Measures

Viewing Contracted Procurement Volumes
- Process: Medical institutions and selected enterprises can use CA certificates to log into Guangdong’s tender and procurement subsystem to view contracted procurement volumes. This transparency helps in planning and managing drug distribution efficiently.
Tripartite Contract Signing
- Procedure: Medical institutions must initiate tripartite contracts through the subsystem, with detailed operational guidance available on the official website. Timely contract completion by all parties is crucial to ensure smooth implementation.
Quality and Supply Assurance
- Responsibility: Drug manufacturers are held accountable for the quality and timely supply of medications. They must ensure coverage across all participating healthcare institutions in the province, emphasizing reliability in the supply chain.

Policy Orientation and Industry Implications
The renewal initiative underscores Guangdong’s commitment to:

Supply Stability: Ensuring uninterrupted drug supply to healthcare facilities.
Quality Control: Maintaining high standards for drug quality through clear accountability.
Efficiency: Streamlining procurement processes to enhance operational effectiveness.

Conclusion
Guangdong’s approach to centralized drug procurement renewal sets a precedent for regional pharmaceutical management, emphasizing reliability, quality, and efficiency. Stakeholders should adhere to these guidelines to optimize compliance and ensure patient access to essential medications.

Policy Source: https://www.gdmede.com.cn/announcement/announcement/detail?id=1905839740230307840

Policy Analysis & Guidance: China Reclassifies Two Traditional Medicines as OTC Drugs

China’s National Medical Products Administration (NMPA) has announced the reclassification of two traditional Chinese medicines—Jingqian Shu Granules and Fufang Taizishen Oral Liquid—from prescription to over-the-counter (OTC) status. The move, effective immediately, reflects Beijing’s ongoing efforts to streamline pharmaceutical access while maintaining safety standards.

Policy Breakdown

Regulatory Framework: The decision follows the Prescription and Non-Prescription Drug Classification Management Measures (Trial), issued by the former SFDA. The NMPA mandates that drug holders revise packaging and package inserts by December 27, 2025, aligning with the Drug Registration Management Measures.
Market Impact: The shift could unlock broader consumer access, particularly for Jingqian Shu (targeting premenstrual syndrome) and Fufang Taizishen (addressing pediatric anemia and poor appetite). Analysts estimate a potential 25–30% increase in sales volume post-conversion.
Compliance Deadlines: Manufacturers must file revised package inserts with provincial authorities by year-end, with all new batches produced post-filing required to use updated labels.

Industry Implications
Pharmaceutical firms stand to benefit from reduced distribution barriers, though heightened emphasis on consumer education is critical. “This transition demands robust self-regulation to prevent misuse,” said Zhang Wei, a senior analyst at China Pharmaceutical Research Institute. Companies like Tong Ren Tang and Yunnan Baiyao may leverage OTC status to expand into e-commerce channels, potentially capturing an additional $150 million in annual revenue.

Consumer Health Angle
The move democratizes access to menstrual health and pediatric care solutions. Jingqian Shu addresses symptoms like premenstrual mood swings and breast tenderness, while Fufang Taizishen targets childhood anemia—a condition affecting 12% of Chinese children under six.

Global Context
China’s OTC market grew 18% in 2024, reaching $28.7 billion. The NMPA’s proactive stance on OTC expansion parallels trends in the EU and U.S., where regulatory harmonization could facilitate cross-border market entry for Chinese OTC products.

Looking Ahead
The December 2025 deadline will test industry agility. Investors should monitor compliance costs versus market expansion potential, with a focus on companies already positioned in OTC distribution networks.

For full regulatory details, refer to the attached variety list and OTC instruction template.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20250403164528182.html

Policy Analysis and Guidance: Jiangsu Province’s Medical Device Quality and Safety Assessment Measures

Jiangsu Provincial Drug Administration has issued new measures for assessing the quality and safety responsibilities of medical device manufacturers. The “Jiangsu Province Medical Device Production Enterprises Quality and Safety Main Responsibility Assessment Measures” aim to strengthen enterprises’ responsibility for quality and safety, enhance regulatory precision, and promote the high-quality development of the medical device industry.

Key Policy Measures

Annual Assessment System
- Frequency: Enterprises are assessed annually based on their performance in fulfilling quality and safety responsibilities.
- Scope: The assessment covers the period from January 1 to December 31 of the previous year. New enterprises and those that have been out of production for over a year are excluded.
Three-Tier Grading System
- Grades: Enterprises are classified into three levels: A (excellent), B (good), and C (average).
- Criteria:
  – A Grade: Score of 90 or above.
  – B Grade: Score between 75 and 89.
  – C Grade: Score below 75.
Immediate Downgrade Mechanism
- Circumstances: Enterprises found with serious violations, product quality issues leading to severe incidents, or failure to recall defective products will be immediately downgraded to C.
Self-Assessment and Reporting
- Process: Enterprises must complete self-assessment by March 31 each year and submit reports to the provincial drug administration’s regulatory platform.
Regulatory Review and On-Site Inspection
- Procedure: Local market supervision bureaus and inspection branches will review self-assessment reports and conduct on-site inspections on no less than 3% of enterprises by May 31.
Incentive and Constraint Mechanisms
- Measures: Enterprises of different grades will face corresponding incentives or constraints to encourage continuous improvement in quality and safety management.

Policy Orientation and Industry Implications
The new assessment measures highlight Jiangsu’s strategic focus on:

Quality and Safety: Prioritizing product reliability and consumer protection.
Regulatory Precision: Enhancing the scientific and precise nature of industry oversight.
Industry Upgrading: Driving the medical device sector toward higher quality and innovation.-China Health Reform Pulse

Policy Source: http://da.jiangsu.gov.cn/art/2025/3/28/art_84620_11527826.html