Category Archives: Other

Policy Analysis and Guidance: Xinjiang’s Priority Registration for Medical Device Applications

Xinjiang’s Drug Evaluation and Inspection Center has released a notice on the priority registration application review results for medical devices (2025 No. 1). This initiative aims to expedite the registration process for specific medical devices, reflecting the region’s commitment to supporting innovation and addressing public health needs.

Key Policy Highlights

Priority Registration Criteria
- Basis: Applications are reviewed under the “Xinjiang Uygur Autonomous Region Second-Class Medical Device Special Registration Procedure” (Announcement No. 39, 2021).
- Purpose: To accelerate the registration of devices that meet specific priority criteria.
Publicize Details
- Period: The public announcement period is from March 24 to 28, 2025.
- Content: Lists the product “Electronic Gastroscopy” by Xinjiang Ruijiang Biotechnology Co., Ltd., which qualifies for priority registration due to meeting specific criteria.
Objection Process
- Contact: Stakeholders with objections are encouraged to contact the center within the announcement period.

Policy Orientation and Industry Implications
The priority registration policy reflects Xinjiang’s strategic focus on:

Innovation Support: Accelerating the market entry of innovative medical devices.
Public Health: Addressing urgent public health needs through faster access to critical devices.
Regulatory Efficiency: Streamlining the registration process to support industry development.

Conclusion
Xinjiang’s priority registration initiative for medical devices sets a precedent for regional regulatory support, emphasizing innovation and public health. Companies in the medical device sector should leverage this policy to expedite product development and market entry.-China Health Reform Pulse

Policy Source: http://mpa.xinjiang.gov.cn/xjyjj/ylqxggtg/202503/b44f72f43777439793f7df0b2bb3673d.shtml

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

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