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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.
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Announcement of the National Medical Products Administration and National Health Commission on Issuing the 2025 Edition of the Pharmacopoeia of the People’s Republic of China (No. 29, 2025)
2025-06-11
According to the Drug Administration Law of the People's Republic of China, the Pharmacopoeia of the People's Republic of China (2025 Edition) (hereinafter referred to as Chinese Pharmacopoeia) has been reviewed and approved by the Plenary Meeting of the Executive Committee of the 12th Chinese Pharmacopoeia Commission.
