Category Archives: Sichuan

Policy Analysis & Guidance: Sichuan’s New TCM Granule Standards (2025)

Leave a reply

The Sichuan Provincial Drug Administration has released its second batch of trial standards for traditional Chinese medicine (TCM) granules, effective immediately. The new regulations, covering 21 herbal formulas including Buchengqie (Litsea cubeba fruit) and Dujiaojin (Striga asiatica), mark a significant step toward standardizing the TCM granule market. The two-year trial period underscores the province’s commitment to balancing traditional practices with modern pharmaceutical compliance.

Key Policy Highlights

  • 21 Granule Formulas Standardized: The standards specify manufacturing processes, active ingredient concentrations, and quality control metrics for each formula. For example, Buchengqie granules must contain 0.2–1.7 mg of rutin per gram, while Dujiaojin requires a minimum 12% ethanol-soluble extract.
  • Dynamic Compliance Framework: Trial standards will automatically expire if national-level regulations are issued during the two-year period, ensuring alignment with overarching Chinese pharmaceutical policies.
  • Enhanced Safety Protocols: Rigorous testing for heavy metals, aflatoxins, and chemical markers (e.g., matrine in Dujiaojin) reflects growing consumer demand for transparency in herbal medicine.

Industry Impact: Modernization vs. Tradition
Pharmaceutical firms operating in Sichuan’s TCM sector face heightened compliance costs but stand to gain from reduced regulatory uncertainty. The standards prioritize scientific validation without discarding traditional extraction methods, a delicate balance that could set a national precedent. Analysts estimate the move could streamline supply chains by 15–20% while elevating export credibility.

Global Implications
As China’s TCM exports reached $6.1 billion in 2024, Sichuan’s trial standards may influence international regulatory frameworks. Companies like Yunnan Baiyao and Tong Ren Tang could leverage these benchmarks to meet EU and U.S. pharmacopeial requirements, potentially unlocking $12 billion in untapped overseas markets.

Expert Reaction
“Standardization doesn’t mean sterilizing tradition—it’s about proving efficacy through modern science,” said Dr. Li Wei, director of the Chengdu Institute of TCM. “Sichuan’s approach could become a blueprint for other provinces.”

Looking Ahead
The trial period concludes in April 2027, with a review likely focusing on scalability and industry feedback. Investors should monitor whether national adoption follows, which would accelerate China’s TCM sector toward a projected $250 billion valuation by 2030.

For full regulatory details, see the attached standards document.

Policy Source:http://yjj.sc.gov.cn/scyjj/c103155/2025/4/2/26ab4079c5f049a0b4dbfb8401cbd41b.shtml

Policy Analysis and Guidance: Sichuan’s Class II Medical Device Initial Registration Product Directory

Leave a reply

Sichuan Provincial Drug Administration has released the initial registration product directory for Class II medical devices for March 2025. This initiative aims to enhance transparency, ensure compliance, and support the development of the medical device industry.

Key Policy Highlights

  1. Registration Information Disclosure
    • Purpose: To provide the public with accurate and timely information on newly registered Class II medical devices.
    • Details: The directory includes detailed registration information for multiple medical device companies, such as Chengdu Kanghuijing Technology Co., Ltd. and Wangcheng Medical Technology (Chengdu) Co., Ltd.
  2. Regulatory Compliance
    • Standards: Ensuring all registered medical devices comply with national standards and regulations.
    • Transparency: Making registration information publicly available to enhance trust and facilitate industry supervision.
  3. Industry Support
    • Development: Supporting the innovation and development of the medical device industry through clear and efficient regulatory processes.
    • Efficiency: Streamlining the registration process to reduce administrative burdens and promote industry growth.

Policy Orientation and Industry Implications
The initial registration product directory policy reflects Sichuan’s strategic focus on:

  • Transparency: Ensuring public access to accurate and timely registration information.
  • Compliance: Strengthening regulatory frameworks to ensure product safety and quality.
  • Industry Growth: Supporting the innovation and sustainable development of the medical device sector.

Conclusion
Sichuan’s approach to Class II medical device initial registration sets a benchmark for regional medical device regulation, emphasizing transparency, compliance, and industry support. Medical device enterprises should align with these guidelines to ensure smooth operations and build public trust.-China Health Reform Pulse

Policy Source: http://yjj.sc.gov.cn/scyjj/c103181/2025/4/1/53dabb2afc2547e4bbc9a1ed78f3ce27.shtml

Policy Analysis and Guidance: Sichuan’s Medical Device Export Sales Certification Announcement

Leave a reply

Sichuan Provincial Drug Administration has released the Medical Device Export Sales Certification Information Announcement (Issue 9, 2025). This initiative aims to provide transparent and accurate information on medical device exports, supporting international market access and enhancing the global competitiveness of domestic medical device enterprises.

Key Policy Highlights

  1. Certification Information Disclosure
    • Purpose: To provide the public and international markets with accurate information on certified medical devices.
    • Details: The announcement includes detailed certification information for multiple medical device companies, such as Sichuan Bomestar Dental Equipment Co., Ltd.
  2. Regulatory Compliance
    • Standards: Ensuring all exported medical devices comply with national standards and regulations.
    • Transparency: Making certification information publicly available to enhance trust and facilitate international trade.
  3. International Market Support
    • Development: Supporting the international expansion of the medical device industry through clear and efficient certification processes.
    • Efficiency: Streamlining the certification process to reduce administrative burdens and promote industry growth.

Policy Orientation and Industry Implications
The export sales certification policy reflects Sichuan’s strategic focus on:

  • Transparency: Ensuring public and international access to accurate certification information.
  • Compliance: Strengthening regulatory frameworks to ensure product safety and quality.
  • Global Competitiveness: Supporting the international development of the medical device sector.

Conclusion
Sichuan’s approach to medical device export sales certification sets a benchmark for regional medical device regulation, emphasizing transparency, compliance, and global competitiveness. Medical device enterprises should align with these guidelines to ensure smooth international operations and build global trust.-China Health Reform Pulse

Policy Source: http://yjj.sc.gov.cn/scyjj/c103180/2025/3/31/8af3a8ea68e1418e93cbeb6915ed4ce7.shtml