2025新实施标准盘点：医疗制药篇——共有476份新标准实施

Core Viewpoint - The implementation of new pharmaceutical standards in 2025 significantly enhances the application of scientific instruments, with chromatography, mass spectrometry, and spectroscopy technologies becoming core methods to promote high-quality regulation of drugs, medical devices, and instruments [1][3]. Group 1: Scientific Instrument Applications - In 2025, a total of 476 new pharmaceutical standards will be implemented, marking a new height in the breadth and depth of scientific instrument applications [3]. - The new standards notably strengthen the use of chromatography, mass spectrometry, and spectroscopy technologies, with methods like gas/liquid chromatography-mass spectrometry (GC-MS/LC-MS) becoming essential for identifying hundreds of toxic substances and drug components in blood, urine, and biological samples [3]. - Inductively coupled plasma mass spectrometry (ICP-MS) has been established as a key standard for detecting 32 trace elements in biological samples and evaluating the performance of medical mass spectrometers [3]. Group 2: Pharmacopoeia Upgrades - The 2025 edition of the "Chinese Pharmacopoeia" promotes innovation in domestic instruments by revising standards for mass spectrometry and nuclear magnetic resonance spectroscopy, significantly enhancing detection efficiency [3]. - The introduction of advanced technologies such as near-infrared spectroscopy and atomic fluorescence spectroscopy replaces traditional toxic reagent testing, embodying the concept of green regulation [3]. Group 3: Focus on Advanced Medical Devices - In the newly implemented medical device standards, high-precision instruments such as artificial intelligence imaging devices, surgical robots, and digital X-ray detectors are highlighted, driving the precision and intelligence of diagnostic and treatment processes [3]. - Scientific instruments are no longer merely auxiliary tools but are now core technological supports for achieving high-quality regulation and ensuring the safety of drugs and devices in the pharmaceutical industry by 2025 [3].