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Drug Standards of China

2002 (v1, n1) to Present ISSN: 1671-8925

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Brief introduction on the development of Chinese Pharmacopoeia 2025 Edition

HONG Xiaoxu ; SONG Zonghua ; MA Shuangcheng ; LAN Fen ; SHU Rong

Drug Standards of China.2025;26(1):001-010. doi:10.19778/j.chp.2025.01.001

The Pharmacopoeia of the People’s Republic of China 2025 edition is to be issued in March 2025. Chinese Pharmacopoeia is the basic requirements on the drug manufacture, drug testing, drug use and drug administration. The new edition Chinese Pharmacopoeia will be dramatically improved on the pharmacopoeia monographs included, establishing the standards system, standards conversion and application of drug quality control for the new technology, new method & new tool, drug control on the safety and effectiveness as well as the drug standard international harmonization. It will take important role on improving the drug quality, ensuring the safety of drugs for public use, strengthen technical support for drug administration, promoting the high-quality development of China’s medical and pharmaceutical industry. This paper introduces the development and revision of the Chinese Pharmacopoeia 2025 Edition,aim at helping the industries well understanding and implantation the new edition Chinese Pharmacopoeia.

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The development and characteristics of general notice in Chinese Pharmacopoeia 2025 Edition

WANG Fei ; SONG Zonghua ; MA Shuangcheng ; SHU Rong

Drug Standards of China.2025;26(1):011-016. doi:10.19778/j.chp.2025.01.002

Objective: Introduce and briefly describe the status, characteristics, and writing ideas of general notice in the Chinese Pharmacopoeia 2025 edition, providing reference and suggestions for better understanding and implementation of the Chinese Pharmacopoeia 2025 edition.
Methods:This article elaborates on the content and revision of general notice in the Chinese Pharmacopoeia 2025 edition from the perspective of frame structure and main contents.
Results:Compared with other pharmacopoeias of various countries, Chinese Pharmacopoeia includes standards for traditional Chinese medicine, chemical drugs, biological products and excipients, pharmaceutical packaging materials, etc. Each section of Chinese Pharmacopoeia has its own general notice, with 34 to 48 items arranged in 11 to 12 chapters. Depending on the type of products included and the development history, the general notice in each section present differences in format and content. Given the importance and significance of the standards in Chinese Pharmacopoeia, it is necessary for the industry to coordinate and unify the general notice in various parts of Chinese Pharmacopoeia. With the introduction and revision of regulations, changes in the content of pharmacopoeias, and the application of new technologies, methods, and concepts in drug quality control, considering the unique characteristics of various drugs in quality control and supervision, Chinese Pharmacopoeia has comprehensively standardized relevant requirements. While taking into account the characteristics of the first, second, third, and fourth parts of the pharmacopoeia, it retains the characteristics of relative uniformity and the content of each part, achieving the unified standardization of the general rules of each general notice in the Chinese Pharmacopoeia 2025 edition and the coordination and consistency of common content.
Conclusion: The current version of Chinese Pharmacopoeia has undergone significant changes and improvements in both form and content. By introducing the overall situation and revised content of general notice in the Chinese Pharmacopoeia 2025 edition, pharmacopoeia users can have a deeper understanding of Chinese Pharmacopoeia and use it correctly.

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Updates and amendments of the Chinese Pharmacopoeia 2025 Edition (Volume Ⅰ)

LI Hao ; SHEN Mingrui ; ZHANG Pang ; ZHAI Weimin ; NI Long ; HAO Bo ; ZHAO Yuxin ; HE Yi ; MA Shuangcheng ; SHU Rong

Drug Standards of China.2025;26(1):017-022. doi:10.19778/j.chp.2025.01.003

The Chinese Pharmacopoeia is the legal technical standard which should be followed during the research, production, use, and administration of drugs. At present, the new edition of the Chinese Pharmacopoeia is planned to be promulgated and implemented. This article summarizes and analyzes the main characteristics and the content of updates and amendments of the Chinese Pharmacopoeia 2025 Edition(Volume Ⅰ), to provide a reference for the correct understanding and accurate implementation the new edition of the pharmacopoeia.

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Introduction of the main addition and revision of the Chinese Pharmacopoeia 2025 Edition(Volume Ⅱ)

ZHOU Yi ; WANG Zhijun ; YUE Zhihua ; CHENG Qilei ; YUE Ruiqi ; YANG Xi ; GUO Wei ; MA Shuangcheng

Drug Standards of China.2025;26(1):023-027. doi:10.19778/j.chp.2025.01.004

The Pharmacopeia of the People’s Republic of China 2025 Edition (referred to as the Chinese Pharmacopoeia 2025 Edition, ChP 2025) will be promulgated and implemented. This article introduces the process of development of ChP 2025 Edition (Volume Ⅱ), including the selection, the revision of general notices,the addition and revision of drug monographs, etc., and provides some analysis and examples to illustrate,which can facilitate the readers to understand and implement the ChP 2025 Edition (Volume Ⅱ).

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Overview of Chinese Pharmacopoeia 2025 Edition Volume Ⅲ

CAO Yan ; ZHAO Xiong ; WANG Xiaojuan ; CHEN Huiyi ; LI Huiyi

Drug Standards of China.2025;26(1):028-033. doi:10.19778/j.chp.2025.01.005

“Chinese Pharmacopoeia” is the legal basis for drug development, production, operation, use and management in China, and the Chinese Pharmacopoeia 2025 Edition is going to be issued and implemented. This article introduces the revision and amendment situations, analyzes the characteristics of the new edition of the Pharmacopoeia and the future development direction of national standards for better understanding and implementation of the latest edition of pharmacopoeia.

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Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition

ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng

Drug Standards of China.2025;26(1):034-044. doi:10.19778/j.chp.2025.01.006

To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines； further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly； replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.

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Additions and revisions of general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ

XU Xinyi ; WEI Shifeng ; ZHANG Qiming ; HE Langchong ; ZHANG Jun ; MA Shuangcheng

Drug Standards of China.2025;26(1):045-050. doi:10.19778/j.chp.2025.01.007

Objective: To provide reference for the correct understanding and accurate implementation of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.
Methods: Introduce the main characteristics and content of the additions and revisions of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.
Results: The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition are more harmonized with the relevant guidelines of the ICH Q series, and the inclusion of advanced and mature instrument analysis technology standards and analysis method standards related to drug safety, efficacy, and quality controllability is further increased.
Conclusion: The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition have provided a more convenient new bridge for China’s drugs to go international, standardized testing technology support for achieving full process quality control, and better meet the needs of drug research and development, production, quality control, and supervision in China.

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The introduction on the revised standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition

CHEN Lei ; LUI Yanming ; YUAN Yaozuo ; CHEN Ying ; DAI Hong ; ZHANG Jun ; MA Shuangcheng

Drug Standards of China.2025;26(1):051-057. doi:10.19778/j.chp.2025.01.008

According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the Chinese Pharmacopoeia 2025 has been completed. Among them, 52 new pharmaceutical excipients monographs have been added, and the total number has reached 387. 245 pharmaceutical excipients monographs have been revised, of which 109 monographs have only textual revisions and 136 monographs have substantive revisions. This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.

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The introduction on the new standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition

CHEN Lei ; CHEN Ying ; TU Jiasheng ; LIU Yanming ; ZHENG Luxia ; ZHANG Jun ; MA Shuangcheng

Drug Standards of China.2025;26(1):058-066. doi:10.19778/j.chp.2025.01.009

According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the Chinese Pharmacopoeia 2025 Edition has been completed. Among them, 52 new pharmaceutical excipients monographs have been added, an increase of 15.5% compared with the 2020 Edition, and the total number has reached 387. This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.

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The introduction on standards system of the pharmaceutical packaging materials in the Chinese Pharmacopoeia 2025 Edition

CHEN Lei ; YU Hui ; WANG Yan ; ZHANG Jun ; MA Shuangcheng

Drug Standards of China.2025;26(1):067-076. doi:10.19778/j.chp.2025.01.010

The standard of Pharmaceutical packaging materials is an important part of the Chinese Pharmacopoeia. This article focuses on working background, general idea, working process, main framework, and its role and significance of the pharmaceutical packaging materials standards system in the Chinese Pharmacopoeia 2025 Edition, which can contribute to accurately understand and utilize the standards in the Chinese Pharmacopoeia 2025 Edition.

Country

China

Publisher

《中国药品标准》编辑部

ElectronicLinks

http://ypbz.cnjournals.com/ch/index.aspx

Editor-in-chief

张伟

E-mail

1484248059@qq.com

Abbreviation

Drug Stand China

Vernacular Journal Title

中国药品标准

ISSN

1009-3656

EISSN

Year Approved

2022

Current Indexing Status

Currently Indexed

Start Year

2000

Description

Drug Standards of China was officially launched on April 18, 2000. It is a professional authoritative publication of national pharmaceutical standards, which is in charge of the National Medical Products Administration and sponsored by the Chinese Pharmacopoeia Commission. It is a characteristic journal that undertakes professional and comprehensive scientific research and academic exchange in the field of pharmaceutical standards in China. It is the only professional journal in China and rare in the world that focuses on reporting research in the field of pharmaceutical standards. Since its inception, it has played an extremely important role in implementing national drug standardization and promoting drug safety, effectiveness and quality control, and its social impact has been expanding and improving day by day. The columns set up in this journal include: review, treatises, standard management and regulations, standard forum, methodological research, excipients and packaging, standards and clinic, etc. This journal is suitable for enterprises, institutions and individuals such as drug research, production and circulation, drug supervision and inspection, and related instrument and equipment manufacturing, especially for practitioners of drug technology and quality management. At present, Drug Standards of China is the statistical source journal of China Academic Journal Comprehensive Evaluation Database, the Full-text Journal of China Journal Full-text Database, the Journal of China Core Journal (selection) database, the Journal of China Academic Journal Evaluation Research Report (Sixth Edition) (selection) database, and the Journal of Chinese scientific and technological data catalog-medical and health collection source, Chemical Abstracts (USA) , CNKI, Wanfang Data, etc.

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