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Policy Interpretation of Provisions on the Experimental Research of Narcotic Drugs and Psychotropic Substances
2025-07-21
To strengthen the safety management of experimental research involving narcotic and psychotropic drugs, the Provisions propose requirements from multiple aspects, including safety management systems and facilities and equipment, entrusted research management, management of experimental researchers, and management of narcotic and psychotropic drugs and active substances.
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NMPA holds meeting to review QMS in vaccine regulation, pharmaceutical manufacturing inspection
2025-07-21
The National Medical Products Administration (NMPA) held a meeting on June 9 to conduct the 2024 annual review of the quality management system (QMS) in vaccine regulation and pharmaceutical manufacturing inspection. NMPA Commissioner Li Li chaired the meeting and fully affirmed the suitability, adequacy, and effectiveness of the NMPA's QMS in these two areas.
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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.
