The 2025 edition of the Pharmacopoeia of the People's Republic of China (referred to as the "Chinese Pharmacopoeia") is the twelfth edition. The Twelfth Pharmacopoeia Commission conscientiously implemented General Secretary Xi Jinping's "four strictest" requirements, aiming to safeguard public health, promote innovative development, and serve drug regulation. Under the deployment of the National Medical Products Administration, and with the active participation of drug inspection agencies at all levels, scientific research institutes and universities, societies, associations, and relevant enterprises, the various tasks for the compilation of the 2025 edition of the Chinese Pharmacopoeia were organized and completed. On November 27, 2024, the plenary meeting of the Executive Committee of the Twelfth Pharmacopoeia Commission reviewed and approved the 2025 edition of the Chinese Pharmacopoeia (draft). In March 2025, the National Medical Products Administration and the National Health Commission issued the "Announcement on the Promulgation of the 2025 Edition of the Pharmacopoeia of the People's Republic of China" (No. 29, 2025). According to the Drug Administration Law of the People's Republic of China, the 2025 edition of the Pharmacopoeia of the People's Republic of China was reviewed and approved by the plenary meeting of the Executive Committee of the Twelfth Pharmacopoeia Commission and will come into force on October 1, 2025.

This edition of the Pharmacopoeia includes a total of 6385 varieties, with 159 new additions, 1101 revisions, and 32 no longer included. Among them, Part I (Traditional Chinese Medicines) includes a total of 3069 varieties, with 28 new additions, 420 revisions, and 19 no longer included; Part II (Chemical Drugs) includes a total of 2776 varieties, with 66 new additions, 483 revisions, and 2 varieties moved to Part IV; Part III (Biological Products) includes a total of 153 varieties, with 13 new additions, 62 revisions, and 13 no longer included; Part IV (Pharmaceutical Excipients) includes a total of 387 varieties, with 52 new additions, and 136 revisions.

This edition of the Pharmacopoeia includes a total of 410 general technical requirements, with 69 new additions and 133 revisions. Among them, Part III has 13 new additions and 31 revisions; Part IV has 56 new additions and 102 revisions.

This edition of the Pharmacopoeia includes a total of 72 guidelines, with 33 new additions, 17 revisions, and 3 no longer included. Among them, Part III has 5 new additions; Part IV has 28 new additions, 17 revisions, and 3 no longer included.

Main features of this edition of the Pharmacopoeia:

Steady increase in the inclusion of Pharmacopoeia varieties. Adhering to clinical orientation, continuously expanding the coverage of the National Essential Medicines List and the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List varieties, and accelerating the inclusion of anti-tumor drugs, monoclonal antibody biosimilars, and pediatric drug varieties, fully demonstrating China's achievements in pharmaceutical technology innovation and further meeting clinical medication needs.

Continuously improving the national drug standard system. Continuously perfecting the "Chinese Pharmacopoeia" standard system, which takes the general notices as basic requirements, general technical requirements as overall provisions, guidelines as technical guidance, and monographs as specific requirements. Achieving unified standardization of the general notices in all parts of the "Chinese Pharmacopoeia" and consistent coordination of common contents. Implementing the concept of drug full lifecycle management, strengthening quality control requirements in drug research, production, circulation, and use, and reinforcing source and process control in drug manufacturing. Continuously improving the quality standard system that conforms to the characteristics of Traditional Chinese Medicine, chemical drugs, and biological drugs, further reflecting the scientificity, standardization, foresight, and guiding role of the "Chinese Pharmacopoeia".

Accelerating the standardization and application of new technologies, new methods, and new tools. Keeping abreast of the latest developments in international pharmaceuticals, focusing on hot areas of the industry, accelerating the standardization of new technologies, new methods, and new tools formed by pharmaceutical innovation, continuously expanding the application of advanced and mature testing technologies, and providing highly standardized, widely applicable, stable, and reliable testing methods for drug quality control. New additions include "Guideline for Biological Assay Based on Genetically Modified Cell Lines", "Guideline for Glycosylation Analysis of Glycoproteins", etc., to improve quality controllability. New additions include "In Vitro Pyrogen Test (Reporter Gene Assay)", "Guideline for Microbiological Examination of Cell-Based Products", etc., to break through technical bottlenecks in the release testing of related products. New addition of "Guideline for Microbial Whole Genome Sequencing Technology" to continuously strengthen the application of molecular biology technology in drug quality control. New addition of "Guideline for Optically Stimulated Luminescence Detection Method for Irradiated Traditional Chinese Medicines", etc., to strengthen technical reserves for drug testing.

Continuously improving drug quality control requirements. Focus on strengthening drug safety and efficacy control, and comprehensively enhancing drug quality controllability. In terms of safety: the control of prohibited pesticide residues in Traditional Chinese Medicinal materials and decoction pieces has increased from 33 to 47 types. Strengthening impurity control requirements for chemical drugs, paying more attention to the source and classification of impurities, and improving methods for separating related substances. New additions include "Technical Guideline for Impurity Control of Human Vaccines", "Guideline for Control of Visible Particulates in Injections", etc., continuously enhancing drug safety control requirements. In terms of efficacy: "Reciprocating Cylinder Method" and "Diffusion Cell Method" have been added to the Dissolution and Release Rate Determination methods, improving quality evaluation methods for oral solid preparations. In terms of quality controllability: New additions include "Method for Biodistribution Determination of Radiopharmaceuticals", "Guideline for Chemical Imaging", "Guideline for Multivariate Statistical Process Control Technology", "Guideline for Chemometrics", etc., guiding the development and establishment of process analytical technology methods, and providing technical support for strengthening quality control throughout the entire drug production process.

Striving for coordination with international standards. Combining China's actual situation and drawing on international standards, continuously promoting coordination with international standards. Through direct coordination, parallel inclusion, and other methods, the conversion and implementation of all 16 ICH Q4B guidelines have been achieved. The general technical requirements such as "Residual Solvents" and "Elemental Impurities" have been revised and added to achieve coordination with ICH Q2, Q3C, Q3D, Q14, and other principles, making critical quality control requirements for drugs more harmonized with international standards.

Strengthening the alignment with technical requirements for review, inspection, and testing. Given that the Center for Drug Evaluation of the National Medical Products Administration has already issued guidelines with the same content as "Guideline for Human Bioavailability and Bioequivalence Studies of Drug Preparations" and "Guideline for Validation of Quantitative Analytical Methods for Biological Samples" in the 2020 edition of the "Chinese Pharmacopoeia", this edition of the Pharmacopoeia will no longer include them. To align with standards promulgated by relevant departments, general principles such as "Management of Repackaging and Storage and Transportation of Biological Products" and "Quality Control of Laboratory Animals for Production and Testing of Biological Products" have been revised.

Further embodying the green and environmental protection concept of drug standards. In accordance with the new development concepts of innovation, coordination, green, openness, and sharing, guidelines for replacing toxic Traditional Chinese Medicine reference substances (such as aconitine, strychnine, etc.) have been formulated. 13 Traditional Chinese Medicine varieties containing pangolin scales in their prescriptions are no longer included. To reduce environmental pollution and minimize harm to personnel, inspection items using highly toxic or controlled reagents have been removed from the monographs of 332 chemical drug varieties.

Pharmacopoeia compilation work is more standardized and rigorous. During the compilation of the 2025 edition of the "Chinese Pharmacopoeia", to further strengthen drug standard management, the National Medical Products Administration successively issued the "Measures for Drug Standard Management" and "Special Provisions for Traditional Chinese Medicine Standard Management". The National Pharmacopoeia Commission continues to improve relevant management documents such as the "Management Measures for Research Projects on Drug Standard Formulation and Revision by the National Pharmacopoeia Commission", establish an information management system for the entire standard research process, achieve full lifecycle management of drug standards, continuously enhance drug standard management capabilities, and further ensure the compilation quality of the "Chinese Pharmacopoeia".

The compilation of this edition of the Pharmacopoeia has consistently adhered to the principles of scientificity, advancement, practicality, and standardization, further solidifying the "Chinese Pharmacopoeia"'s position as the core of national drug standards, making the standard system more complete, drug quality more controllable, more harmonized with international standards, and elevating the overall level of national drug standards to a new height. The promulgation and implementation of this edition of the Pharmacopoeia will play an important role in ensuring drug quality, promoting technological upgrading of the pharmaceutical industry, strengthening standard support for drug regulation, ensuring public drug safety, promoting high-quality development of the pharmaceutical industry, and enhancing China's international competitiveness in pharmaceutical manufacturing.

National Pharmacopoeia Commission

March 2025