曲妥珠(单抗)
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2025版中国药典实施!19项技术空白填补,分析仪器检测标准全面升级
仪器信息网· 2025-10-09 09:05
Core Viewpoint - The 2025 edition of the "Pharmacopoeia of the People's Republic of China" officially implemented on October 1, 2025, serves as a critical standard for drug safety and a guide for the development of the pharmaceutical industry in China [3][4]. Summary by Sections New Additions and Revisions - The new edition includes 159 newly added varieties and 1,101 revised varieties, totaling 6,385 varieties [3][4]. - It introduces 69 new general technical requirements and revises 133, along with 33 new guiding principles and 17 revisions [3]. Focus on Domestic Innovations - The pharmacopoeia emphasizes the inclusion of domestically developed drugs with independent intellectual property rights, such as trastuzumab and rituximab, marking their first inclusion in an international pharmacopoeia [4][5]. - It highlights the addition of five anti-tumor drugs and medications for pediatric use, such as growth hormone for treating children's growth disorders [4]. Safety Standards and International Alignment - The new edition raises safety standards for drug residues, increasing the number of controlled pesticide residues in traditional Chinese medicine from 33 to 47 [7]. - It aligns with international standards, facilitating the registration process for Chinese drugs abroad and enhancing the global competitiveness of Chinese pharmaceuticals [7][8]. Comprehensive Drug Standards - The pharmacopoeia covers a wide range of categories, including traditional Chinese medicine, chemical drugs, biological products, excipients, and packaging materials, establishing a comprehensive national drug standard system [8].