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: Guangdong Province’s Volume-Based Drug Procurement Initiative

Guangdong Province’s Drug Exchange Center has issued a notice outlining the implementation details of the centralized volume-based procurement initiative for medications such as Apixaban tablets. This policy, effective from April 1, 2025, to December 31, 2025, aims to streamline drug procurement processes, enhance supply chain stability, and ensure quality assurance across healthcare institutions.

Key Policy Measures

Tripartite Contract Signing
- Process: Medical institutions must use CA certificates to log into Guangdong’s tender and procurement subsystem to initiate tripartite contracts. Detailed operational guidance is available on the official website.
- Timeline: Contracts must be completed promptly after initiation by medical institutions, with drug manufacturers and distributors required to log in and finalize agreements without delay.
Quality and Supply Responsibility
- Accountability: Drug manufacturers are designated as the primary responsible parties for ensuring the quality and timely delivery of medications. They must guarantee coverage of all participating healthcare institutions across the province.
- Compliance: Selected manufacturers must adhere to agreed-upon procurement volumes and ensure uninterrupted supply chains.
Procurement Volume Negotiation
- Flexibility: For designated social healthcare institutions, procurement volumes will be determined through negotiations between supply and demand parties, allowing for tailored agreements.

Policy Orientation and Industry Implications
This initiative reflects Guangdong’s strategic focus on:

Cost Efficiency: Reducing drug prices through centralized procurement while maintaining quality standards.
Supply Chain Integrity: Ensuring uninterrupted medication supply to healthcare facilities across the province.
Transparency: Promoting clear contractual agreements and accountability mechanisms.

Conclusion
Guangdong’s volume-based procurement framework sets a benchmark for regional drug management, emphasizing efficiency, quality, and accessibility. Stakeholders, including manufacturers, distributors, and healthcare providers, should align their operations with these guidelines to optimize compliance and patient outcomes.-China Health Reform Pulse

Policy Source: https://www.gdmede.com.cn/announcement/announcement/detail?id=1906642648857317376

Policy Analysis and Guidance: Yunnan Province’s Revised Technical Guidelines for Chinese Herbal Medicine Quality Standards

Yunnan Province’s Drug Administration has released a revised version of the “Technical Guidelines for the Quality Standards Research of Chinese Herbal Medicines,” aiming to enhance the quality and safety of traditional herbs, promote innovation, and align with national regulatory standards. This revision reflects Yunnan’s strategic focus on leveraging its unique herbal resources and ethnic medical practices to drive industry modernization and internationalization.

Key Policy Revisions

Emphasis on Unique and Ethnic Characteristics
- Objective: Protect Yunnan’s distinctive herbal advantages and enrich the knowledge base of ethnic medicinal practices.
- Implementation: The revised guidelines provide comprehensive solutions for organizing and summarizing historical and regional medication habits, linking clinical positioning with safety information through real-world data.
Enhanced Operability
- Details: Specific requirements for research objectives, methods, and standards have been added, including detailed guidance on historical literature collection, clinical data collection, and toxicity trial requirements.
- Impact: Facilitates consensus between researchers and regulators, streamlining the standard-setting and revision processes.
Innovation and Technological Integration
- Encouragement: Reduced barriers for researchers and increased emphasis on leveraging new technologies for accurate identification and component analysis.
- Outcome: Aims to establish new local standards or elevate existing ones, supporting the modernization and global reach of Yunnan’s herbal industry.
Environmental and Sustainable Development Focus
- Measures: Emphasizes compliance in sample collection and encourages research samples from cultivation bases to protect ecological resources.

Policy Orientation and Industry Implications
The revised guidelines position Yunnan as a leader in traditional Chinese medicine (TCM) standardization by:

Quality Enhancement: Strengthening safety and efficacy through rigorous research protocols.
Industry Support: Providing clear pathways for standard development and international market access.
Eco-Friendly Practices: Promoting sustainable resource management to ensure long-term supply stability.

Conclusion
Yunnan’s updated framework for herbal medicine standards not only solidifies the province’s role in preserving traditional knowledge but also paves the way for scientific innovation and global competitiveness. Stakeholders in the TCM sector should align with these guidelines to capitalize on Yunnan’s unique ecological and cultural advantages while meeting evolving regulatory expectations.-China Health Reform Pulse

Policy Source: https://mpa.yn.gov.cn/newsite/ZwgkNewsView.aspx?ID=2c531135-46bf-4ad1-b65e-a85c4eea9e64