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ISSUING AUTHORITIES:

National Medical Products Administration

National Health Commission

DATE OF ISSUANCE:

March 25, 2025

EFFECTIVE DATE:

October 1, 2025

The 2025 edition of the Pharmacopoeia of the People’s Republic of China (the “2025 Edition Pharmacopoeia”), jointly promulgated by the National Medical Products Administration and the National Health Commission on March 25, 2025, will officially come into effect on October 1, 2025. As the authoritative core of China’s drug quality standards, the 2025 Edition Pharmacopoeia comprehensively enhances drug safety and quality control levels through systematic innovation, injecting new momentum for high-quality development into the pharmaceutical industry. The key points of this revision are as follows:

1.Scientific Upgrade, Fortifying the Safety Baseline: The 2025 Edition Pharmacopoeia adds 159 new monographs and revises 1101 existing ones, with a focus on strengthening quality control requirements for traditional Chinese medicine (TCM), biologics, and high-risk drugs. In the field of TCM, 28 new standards for crude drugs and processed Chinese material medica are included, and for the first time, residue limits for plant growth regulators (such as uniconazole in Ophiopogon japonicus) and 47 prohibited pesticides in TCM are established, further ensuring the safety of traditional medicine.

2.Technological Innovation, Driving Industrial Transformation: The 2025 Edition Pharmacopoeia introduces several international cutting-edge testing technologies, such as inductively coupled plasma mass spectrometry (ICP-MS) for heavy metal risk assessment, and promotes photostimulated luminescence (PSL) detection technology for irradiated TCM to standardize sterilization processes. Simultaneously, the physicochemical analysis technical requirements of Volume IV of the Pharmacopoeia are fully aligned with ICH international guidelines, promoting the technological upgrading of domestically produced testing equipment (such as near-infrared spectrometers and intelligent dissolution testers) and accelerating the substitution of imported scientific instruments with domestic ones.

3.Global Vision, Enhancing International Competitiveness: By translating ICH Q-series guidelines and adopting internationally accepted testing methods, the 2025 Edition Pharmacopoeia significantly enhances China’s global influence in drug standards. TCM standards are participating in the formulation of the WHO International Herbal Pharmacopoeia, and chemical drug standards are aligning with USP/EP, clearing technical barriers for the export of domestically produced drugs.

The promulgation of the 2025 Edition Pharmacopoeia marks China’s drug regulation’s leap from “catching up” to “running alongside”, safeguarding public health with the most stringent standards while providing strategic support for technological innovation, green transformation, and internationalization of the pharmaceutical industry.

Reference:

國家藥監局關于實施2025年版《中華人民共和國藥典》有關事宜的公告（2025年第32號）