Category Archives: Other

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

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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

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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

Policy Analysis and Guidance: Shanghai Announces Second Supply and Incomplete Specification Enterprises for National Drug Procurement

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Shanghai’s Medical Centralized Bidding and Procurement Affairs Management Office has released a notice announcing the determination of second supply and incomplete specification supply enterprises for the tenth batch of national centralized drug procurement. This initiative aims to ensure the stability of drug supply and adaptability to market dynamics, reflecting Shanghai’s commitment to optimizing its centralized procurement system.

Key Policy Highlights

  1. Second Supply and Incomplete Specification Enterprises
    • Purpose: To address market gaps and ensure uninterrupted drug supply.
    • Criteria: Determined based on market share and economic factors.
  2. Market Dynamics Adaptation
    • Flexibility: Provides flexibility in responding to market changes and supply chain disruptions.
  3. Attachment Details
    • Lists: Includes detailed lists of second supply and incomplete specification supply drugs for reference by relevant stakeholders.

Policy Orientation and Industry Implications
The announcement reflects Shanghai’s strategic focus on:

  • Supply Chain Resilience: Ensuring continuous drug availability through diversified supply sources.
  • Market Adaptability: Adapting procurement strategies to meet evolving market conditions.
  • Transparency: Enhancing clarity and accessibility of procurement information for stakeholders.

Conclusion
Shanghai’s approach to determining second supply and incomplete specification enterprises underscores its commitment to maintaining a stable and responsive pharmaceutical market. This policy supports the reliability of the centralized procurement system and ensures patient access to essential medications. Stakeholders should stay informed of these updates to maintain operational efficiency and compliance.-China Health Reform Pulse

Policy Source: https://www.smpaa.cn/xxgk/gggs/2025/03/26/16522.shtml

Policy Analysis and Guidance: China’s Centralized Drug Procurement Information Change Notification

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China’s National Joint Procurement Office has issued a notification regarding the information change of selected drugs in the national centralized drug procurement. This notification allows for changes in drug marketing authorization holders, manufacturers, specifications, packaging, and enterprise names under certain conditions, while maintaining the selected status of the drugs. This move aims to enhance the flexibility and adaptability of the centralized procurement system, ensuring the continuity and stability of drug supply.

Key Policy Highlights

  1. Information Change Allowance
    • Conditions: Under specific conditions, changes in drug-related information are permitted without losing the selected status.
    • Purpose: To maintain the stability of the drug supply chain and adapt to market changes.
  2. Regulatory Compliance
    • Material Review: The change applications are subject to strict verification to ensure compliance with regulatory standards.
  3. Market Implications
    • Supply Stability: Ensures uninterrupted drug supply by allowing necessary information adjustments.
    • Industry Adaptability: Provides flexibility for enterprises to respond to market dynamics while maintaining their position in the procurement system.

Policy Orientation and Industry Implications
The notification reflects China’s strategic focus on:

  • Supply Chain Resilience: Prioritizing the stability and continuity of drug supply.
  • Regulatory Flexibility: Adapting regulatory measures to support industry dynamics and market changes.
  • Market Stability: Ensuring the centralized procurement system remains effective and responsive to industry needs.

Conclusion
China’s approach to allowing information changes in selected drugs under the centralized procurement system demonstrates a balance between regulatory rigor and industry flexibility. This policy supports the stability of the pharmaceutical market and ensures patient access to essential medications. Stakeholders should stay informed of these changes to maintain compliance and operational efficiency.-China Health Reform Pulse

Policy Source: https://www.smpaa.cn/gjsdcg/2025/03/26/16521.shtml