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

1. 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.
2. 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.
3. 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.
4. 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

China’s National Medical Products Administration (NMPA) has approved Elbasvir, an innovative 1-class drug developed by YiChang HEC ChangJiang Pharmaceutical Co., Ltd. This drug, to be marketed under the brand name Dongyinghe, is indicated for the treatment of adult chronic hepatitis C virus (HCV) infections in genotypes 1, 2, 3, and 6, including patients with compensated liver cirrhosis. The approval highlights China’s ongoing commitment to enhancing pharmaceutical innovation and regulatory efficiency.

Key Policy Highlights

1. Innovative Treatment Option
   • Indication: Elbasvir is approved for use in combination with netasavir capsules to treat HCV infections, offering a new therapeutic choice for patients.
   • Patient Population: Targets both treatment-naïve and interferon-treated patients, expanding accessibility to effective therapy.
2. Regulatory Efficiency
   • Approval Process: The rapid approval reflects NMPA’s efforts to accelerate the market entry of innovative drugs, aligning with global regulatory standards and practices.
3. Market Implications
   • Therapeutic Landscape: Elbasvir’s entry diversifies treatment options for HCV, potentially improving patient outcomes and reducing the disease burden.
   • Competitive Edge: The drug’s approval underscores China’s progress in developing domestically innovated therapies competitive with international standards.

Policy Orientation and Industry Implications
The approval of Elbasvir underscores China’s strategic focus on:

• Innovation Support: Encouraging domestic R&D of first-in-class drugs to address unmet clinical needs.
• Regulatory Streamlining: Accelerating approval processes to bring novel therapies to market faster.
• Public Health Impact: Enhancing treatment accessibility and outcomes for HCV patients, contributing to public health goals.

Conclusion
Elbasvir’s approval marks another milestone in China’s journey toward becoming a global leader in pharmaceutical innovation. This development not only benefits HCV patients by providing a new treatment option but also signals China’s growing capability in developing and regulating innovative therapies. Stakeholders in the healthcare sector should leverage this momentum to drive further advancements in drug development and regulatory science.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20250327113342139.html

China’s National Medical Products Administration (NMPA) has approved the innovative anti-influenza drug Masutrelavir (brand name: 伊速达) developed by Jiangxi Kerui Pharmaceutical Co., Ltd. This first-in-class drug offers a new treatment option for influenza patients, highlighting China’s progress in pharmaceutical innovation and regulatory efficiency.

Key Policy Highlights

1. Innovative Mechanism of Action
   • Target: Masutrelavir is a polymerase acidic protein (PA) inhibitor, distinguishing itself from traditional neuraminidase inhibitors by intervening earlier in the viral life cycle to prevent mature virus formation.
   • Clinical Efficacy: Phase III clinical trial data published in Nature Medicine showed significant reductions in symptom resolution time and viral load, with excellent safety and low resistance rates.
2. Regulatory Efficiency
   • Approval Timeline: The rapid approval reflects NMPA’s commitment to accelerating the market entry of innovative drugs, aligning with global regulatory standards.
3. Market Implications
   • New Treatment Option: Masutrelavir provides a one-dose treatment regimen, enhancing patient compliance and offering a competitive edge over existing therapies like oseltamivir and baloxavir.
   • Market Stabilization: The drug’s entry is expected to diversify treatment options and potentially stabilize the influenza medication market.

Policy Orientation and Industry Implications
The approval underscores China’s strategic focus on:

• Innovation Support: Encouraging domestic R&D of first-in-class drugs.
• Regulatory Streamlining: Accelerating approval processes for high-impact innovations.
• Public Health: Enhancing treatment accessibility and outcomes for influenza patients.

Conclusion
Masutrelavir’s approval marks a significant step in China’s journey toward becoming a global leader in pharmaceutical innovation. Stakeholders in the healthcare sector should leverage this momentum to drive further advancements in drug development and regulatory science.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20250327113047141.html