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Policy Analysis and Guidance: Zhejiang Provincial Drug Administration’s Major Administrative Decision-Making Plan for 2025

The Zhejiang Provincial Drug Administration has released its 2025 Major Administrative Decision-Making Plan, outlining key initiatives aimed at enhancing drug and cosmetic safety, strengthening credit management systems, and advancing regulatory mechanisms. This policy framework reflects the province’s commitment to aligning with national regulatory standards while fostering innovation and compliance within the pharmaceutical and cosmetics industries.

Key Policy Initiatives

Zhejiang Drug Safety “15th Five-Year” Plan
- Objective: Establish a comprehensive safety framework for the pharmaceutical sector, covering drug production, distribution, and quality control.
- Implementation: Led by the Planning, Finance, and Technology Department, the plan will undergo public consultation, expert review, and legal scrutiny, with completion slated for June 2026.
- Impact: Expected to streamline regulatory processes and enhance transparency, supporting long-term industry growth and consumer protection.
Credit Management System for Drug Manufacturers
- Objective: Introduce a credit evaluation mechanism to incentivize compliance and penalize violations among drug producers.
- Implementation: Managed by the Drug Production Supervision Department, the system will integrate public feedback, competitive fairness reviews, and legal validation, targeting completion by December 2025.
- Impact: Promote accountability and elevation industry standards, aligning with national credit system construction initiatives.
Credit Evaluation Framework for Cosmetic Enterprises
- Objective: Develop a credit scoring system for cosmetic registrants, filers, and manufacturers to ensure quality and safety.
- Implementation: Spearheaded by the Cosmetics Supervision Department, the framework will incorporate public input, competitive reviews, and legal checks, aiming for completion by August 2025.
- Impact: Enhances regulatory oversight and consumer confidence in the cosmetics sector.

Policy Orientation and Industry Implications
The 2025 plan underscores Zhejiang’s strategic focus on:

Regulatory Modernization: Transitioning toward data-driven and credit-based supervision.
Industry Compliance: Encouraging enterprises to prioritize quality and safety through transparent evaluation systems.
Public Engagement: Prioritizing stakeholder input to ensure policies reflect practical industry needs.

Conclusion
Zhejiang’s proactive regulatory approach positions the province as a leader in pharmaceutical and cosmetics governance. Companies operating in these sectors should prepare for heightened compliance expectations and leverage the upcoming frameworks to strengthen market credibility and operational efficiency.-China Health Reform Pulse

Policy Source: http://mpa.zj.gov.cn/art/2025/3/31/art_1228989285_58939952.html

Policy Analysis and Guidance: China’s Medical Device Regulation and Innovation Push

On March 29, 2025, Xu Jinghe, Vice Minister of China’s National Medical Products Administration (NMPA), conducted a field research in Qingdao, visiting medical device companies and a hospital to understand the innovation and quality supervision of the medical device industry. Xu emphasized the importance of implementing the “four strictest” requirements, strengthening the quality responsibility system, and promoting innovation in the medical device sector.

Key Policy Highlights

Quality and Safety Supervision
- Stringent Requirements: Adherence to the “four strictest” principles to ensure the safety and quality of medical devices.
- Lifecycle Regulation: Enhancing supervision across the entire lifecycle of medical devices, from production to distribution and usage.
Enterprise Responsibility
- Accountability: Medical device manufacturers are the primary responsible parties for product quality and safety.
- Compliance: Ensuring enterprises strictly comply with regulatory standards and maintain quality management systems.
Support for Innovation
- Mechanism Improvement: Establishing and improving mechanisms to support the development of innovative medical devices.
- Regulatory Capacity: Strengthening the regulatory system and capacity building to facilitate research, development, and innovation in the medical device industry.
Industry Development
- High-Quality Growth: Promoting high-quality development of the medical device industry through policy support and regulatory optimization.

Policy Orientation and Industry Implications
Xu’s research and remarks highlight the Chinese government’s strategic focus on:

Safety Assurance: Prioritizing the safety and quality of medical devices through rigorous regulatory measures.
Innovation Drive: Encouraging innovation to enhance the competitiveness and technological level of the medical device industry.
Industry Support: Creating a favorable policy environment to support the sustainable and high-quality development of the sector.

Conclusion
China’s enhanced focus on medical device regulation and innovation reflects its commitment to improving public health outcomes and fostering a robust medical device industry. Companies in the sector should align with these policy directions to ensure compliance while leveraging innovation to gain a competitive edge in the market.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/yaowen/ypjgyw/ylqxyw/20250330085803195.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