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NMPA Announcement on Further Improvement and Optimization of Matters Concerning the Production of Imported Medical Devices in Domestic Enterprises in China (No. 30, 2025)
2025-06-11
To thoroughly implement the decisions of the CPC Central Committee and the State Council on advancing high-level opening-up, fully carry out the requirements of the Opinions of the General Office of the State Council on Comprehensively Deepening the Regulatory Reform of Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry (GBF [2024] No. 53), continuously deepen the reform of medical device regulation, and promote the high-quality development of the medical device industry, the following adjustments and optimizations are hereby made to certain provisions of the Announcement.
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NPMA Announcement on Expanding the Implementation Scope of Electronic Common Technical Documents (No.10, 2025)
2025-06-11
To accelerate the implementation process of the Electronic Common Technical Document (eCTD) in China and enhance the service capabilities of "Internet + Drug Regulation" applications, the following matters concerning the expansion of the eCTD implementation scope are hereby announced.
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Netanasvir Phosphate Capsules Approved for Marketing by China NMPA
2025-06-11
Recently, the Class 1 innovative drug Netanasvir Phosphate Capsules (trade name: 东卫卓/Dongweizhuo) of Sunshine Lake Pharma Co., Ltd. is approved for marketing by China NMPA.
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Finotonlimab Injection Approved for Marketing by China NMPA
2025-06-11
Recently, the Finotonlimab Injection (trade name: 安佑平/Anyouping) of Sino Cell Technologies Inc. is approved for marketing by China NMPA. Indications: This product is indicated for first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck in combination with platinum-containing chemotherapy.
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Siltartoxatug Injection Approved for Marketing by China NMPA
2025-06-11
Recently, the Siltartoxatug Injection (trade name: 新替妥/Xintituo) of Zhuhai Trinomab Pharmaceutical Co., Ltd. is approved for marketing through the priority review and approval procedure by China NMPA. This product is indicated for emergency prophylaxis of tetanus in adults.
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Innovative TCM Compound Binafuxi Granules Approved for Marketing by China NMPA
2025-06-11
Recently, the Class 1.1 innovative traditional Chinese medicine (TCM) Compound Binafuxi Granules of Xinjiang Yinduolan Uighur Medicine Co., Ltd. is approved for marketing by China NMPA.
