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

Published by Thy Nguyen on March 20, 2025

1. Major Updates and Amendments

1.1 Aspects of Safety Control for Chinese Medicine

The 2025 Edition of the Chinese Pharmacopoeia deeply implements the requirements of the “Opinions” for “strictly managing the use of pesticides, fertilizers, and plant growth regulators; formulating pesticide residue and heavy metal limit standards for Chinese medicinal materials by region and by variety; strengthening the control of exogenous harmful substances in Chinese medicines, such as banned pesticides, used pesticides, plant growth regulators, heavy metals, and organic elements; and raising the baseline for quality standards of Chinese medicinal materials.”

1.1.1 Pesticide Residues

Control over banned pesticides will be further strengthened, expanding the number of banned pesticide varieties and improving the overall control level of pesticide residues in Chinese medicine. The requirements for the use of pesticides, plant growth regulators, etc., in the Chinese medicinal materials and decoction pieces recorded in the Pharmacopoeia will be further regulated. It is planned to revise the requirements concerning 33 varieties of banned pesticides and the use of pesticides and plant growth regulators.

1.1.2 Heavy Metals and Harmful Elements

The requirement to formulate heavy metal and harmful element limits for Chinese medicinal materials based on different cultivation environments and the principle of “risk assessment and control” is implemented. The General Chapter on Heavy Metals and Harmful Elements Detection in Medicinal Materials and Decoction Pieces (General Chapter 0212) regulates the detection requirements for heavy metals and harmful elements.

The “Heavy Metals and Harmful Elements” test item has been removed from the monograph text for 13 varieties including Chuanxiong Rhizome (Chuanxiong), Scutellaria Root (Huangqin), etc., which now implement the relevant requirements in General Chapter 0212. Conversely, the “Heavy Metals and Harmful Elements” test item has been newly added to the monograph text for Chuanxiong and Coptis Rhizome (Huanglian) and 5 other varieties. The content of this item for 5 varieties, including Ginseng (Renshen), Cornus Fruit (Shanzhuyu), etc., has not been revised and remains consistent with the 2020 Edition. After adjustment, the 2025 Edition of the Chinese Pharmacopoeia (Part I) includes a total of 7 varieties of botanical Chinese medicinal materials that contain the “Heavy Metals and Harmful Elements” test item.

1.1.3 Plant Growth Regulators

In terms of establishing limit standards for Chinese medicinal material plant growth regulators, the limit standards for Chinese medicinal material plant growth regulators were established for the first time, providing a reference for the formulation of limit indicators for other plant growth regulators.

1.1.4 Mycotoxins/Aflatoxins

The 2025 Edition of the Chinese Pharmacopoeia further strengthened the control of mycotoxins in Chinese medicinal materials and decoction pieces, including adding the inspection of Aflatoxin B2, Ochratoxin A, etc.

1.1.5 Perfecting Inspection Methods for Exogenous Harmful Substances in Chinese Medicine

The 2025 Edition of the Chinese Pharmacopoeia established and perfected the detection methods for exogenous harmful substances, improving the specificity, accuracy, and stability of detection. This included revising General Chapter 2341 (“Determination of Pesticide Residues”) and revising the detection method for “Cadmium, Lead, Arsenic, and Mercury” (General Chapter 2321).

Table 1: Updates and Amendments to Registration Categories and General Chapters Related to Traditional Chinese Medicine Standards

Category	Updates and Amendments	Relevant Content
General Chapters	New Addition	General Chapter on the Determination of Limits for Botanical Antibiotics (General Chapter 2342).
	Revision	General Chapter 0212 “General Chapter on the Inspection of Medicinal Materials and Decoction Pieces.”
		Adding limits for pesticide residues for 14 Chinese medicinal materials; revising limits for pesticide residues for 33 Chinese medicinal materials; adding and revising limit requirements for plant growth regulators.
		Revising General Chapter 2341 “Determination of Pesticide Residues.”
		Revising the determination method for “Cadmium, Lead, Arsenic, and Mercury” (General Chapter 2342).
		Adding “Guideline on Photodegradation Testing in Traditional Chinese Medicines” (Guideline 9261).
Regulation	New Addition	Total number of banned pesticide varieties in the 2025 Edition has increased to 47.

Table 2: Safety Control Items of Chinese Crude Drugs with Plant Origin and Relevant Content (Partial)

Item	Updates and Amendments
Pesticide Residues	The number of banned pesticide varieties in the 2025 Edition has increased to 47.
Heavy Metals and Harmful Elements	Detection requirements for “Heavy Metals and Harmful Elements” have been added for 14 Chinese medicinal materials.
Plant Growth Regulators	The limits for plant growth regulators in Chinese medicinal materials have been revised.
Mycotoxins	Aflatoxin B1, Aflatoxin B2, and other detection items.

1.2 Updates and Amendments to Medicinal Material and Decoction Piece Monographs

1.2.1 Perfecting Medicinal Material Standards

Based on the textual research work of medicinal materials [4], combined with botanical and zoological taxonomy research, the corresponding standards are revised for those that have reached a consensus or have been confirmed domestically and internationally; standards that have not yet reached a consensus or have not been confirmed are temporarily not revised. Currently, the 2025 Edition of the Chinese Pharmacopoeia (Part I) has revised, standardized, and corrected the names of Chinese medicinal materials such as Ophiopogon Tuber (Maidong), Pine Pollen (Songhuafen), Turtle Shell (Biejia), and Centipede (Wugong), as well as their Latin names.

1.2.2 Perfecting Decoction Piece Standards

Chinese herbal decoction pieces are widely used in TCM clinical practice, primarily in the form of decoctions. Based on the characteristics of clinical use of decoction pieces, the 2025 Edition of the Chinese Pharmacopoeia continues to supplement and perfect the five basic quality control indicators for decoction pieces: characteristics, impurities, moisture, ash, and extractives. A total of over 100 decoction piece standards have been revised, and the standards for decoction pieces have been further improved and perfected.

1.2.3 Perfecting and Standardizing the Processing Methods for Chinese Herbal Decoction Pieces

Based on traditional processing theory and enterprise production practice, the Pharmacopoeia Commission organized the formulation of the National Standardized Processing Specifications for Chinese Herbal Decoction Pieces (hereinafter referred to as the “National Processing Specifications”). The National Processing Specifications serve as the national drug standards for Chinese herbal decoction pieces and are mutually supplementary with the implementation of the Chinese Pharmacopoeia [6]. Currently, 61 varieties have been promulgated and implemented, gradually forming a standard system for decoction pieces dominated by the Chinese Pharmacopoeia and supplemented by the National Processing Specifications.

1.2.4 Revision of Characteristics and Microscopic Identification of Chinese Medicinal Materials and Decoction Pieces

Microscopic identification, including tissue identification and powder identification, is an important method for distinguishing the authenticity of Chinese medicines. It is of great significance for identifying Chinese medicinal materials and decoction pieces whose characteristics are not obvious, are easily mixed, or are broken [3]. The “characteristics” of Chinese medicinal materials and decoction pieces are important items for judging authenticity and quality, and are an important component of quality standards [7]. Targeting issues that the industry has frequently reported, the Pharmacopoeia Commission organized multiple drug inspection agencies and research institutes to conduct special research on the microscopic identification and characteristics of over 200 varieties of Chinese medicinal materials and decoction pieces. Based on the research findings, the characteristics and microscopic identification items for over 60 varieties have been revised.

1.2.5 Newly Added Varieties and Specifications for Decoction Pieces

The 2025 Edition of the Chinese Pharmacopoeia has added some decoction piece varieties and specifications. Their selection principles are consistent with the current Pharmacopoeia: the traditional decoction piece forms commonly used in clinical practice; clear source verification; corresponding medicinal material standards have been included in the current Pharmacopoeia; clear processing technology; and reasonable processing methods [4]. For example, the medicinal material Sanqi (Notoginseng) is hard and difficult to crush, and the Pharmacopoeia previously only included the “Sanqi powder” decoction piece. With the continuous improvement of living standards, the dosage of Sanqi has increased, and powder processing has become more convenient. To meet clinical medication needs, based on the aforementioned selection principles, the Pharmacopoeia added the Sanqi Jingzhi decoction piece and stipulated that it must be “crushed or ground into powder when used.”

1.2.6 Scientific Revision of Decoction Piece and Medicinal Material Standards

For issues such as the disconnect between medicinal material and decoction piece standards and unreasonable limit settings, the Pharmacopoeia Commission carried out special research. Based on the research findings, the total ash limit for Chuanxiong decoction pieces was scientifically adjusted, along with the water limit, the limit on extractives from rhubarb charcoal, and the total ash limit for stir-fried Atractylodes decoction pieces. Because polysaccharides hydrolyze during the processing (pao zhi) process, leading to a decrease in content, the polysaccharide content determination item for Jiu Huangjing (processed rhizome of King Solomon’s seal) was deleted to prevent situations where insufficient processing might occur. Due to potential interference in the chromatogram peaks, the content determination item for Onjisaponin III in Yuanzhi (Polygala root) [8] was deleted.

1.3 Proprietary Chinese Medicines and Single-Ingredient Preparations

Chinese medicinal materials are an important component of Chinese medicine preparations, and their quality directly affects the safety and efficacy of clinical medication. Improving the quality standards of Chinese medicine is important for safeguarding the safety of public medication. The 2025 Edition of the Chinese Pharmacopoeia plans to revise and amend over 200 varieties of Proprietary Chinese Medicines and delist 19 varieties. The main content focuses on being guided by TCM clinical practice, adjusting the Proprietary Chinese Medicine standard system to the regulatory level, further standardizing the expression of Proprietary Chinese Medicine varieties included in the Pharmacopoeia, and exploring the formulation of upper and lower limits for the determined content.

1.3.1 Variety Addition and Delisting

The 2025 Edition of the Chinese Pharmacopoeia involves the adjustment of 47 varieties. In terms of variety selection, the principle of “clinically commonly used, definite efficacy, safe medication, mature technology, and controllable quality” is adhered to, with 28 decoction pieces newly added, further expanding the coverage of the National Essential Medicines Catalogue and National Basic Health Insurance Drugs Catalogue. Regarding variety delisting, according to the Compilation Outline for the 2025 Edition of the Chinese Pharmacopoeia, proprietary Chinese medicines that use wild endangered animals and plants as raw materials will no longer be included, nor will proprietary Chinese medicines that have been used clinically for a long time without approval numbers, such as Jiusheng Powder, Zhuli Datan Pills, Yangdan Pills, Huixiang Juhe Pills, and 19 other varieties. In addition, the 2025 Edition of the Chinese Pharmacopoeia has not newly added Chinese medicine varieties containing wild endangered animal or plant raw materials.

1.3.2 Standardizing the Expression of Chinese Medicinal Material Specifications

The former State Drug Administration issued the Technical Guidelines for the Specification Expression of Proprietary Chinese Medicines in 2017. The NMPA requires further compliance with national drug standard revisions and post-market changes to supplement and gradually standardize the expression of Proprietary Chinese Medicine specifications. During the compilation of the 2025 Edition of the Chinese Pharmacopoeia, in accordance with the aforementioned guiding principles, the expression of specifications for newly added and revised varieties has been standardized, clearly eliminating the theoretical quantity (or labeled quantity) of the prescription dose (including decoction pieces, extracts, active ingredients, etc.) for the Proprietary Chinese Medicine monograph, and simultaneously revising the expression of limits and other relevant content.

1.3.3 Perfecting the Registration Standards for Proprietary Chinese Medicines

Combining issues identified during drug regulatory work, the standards for Proprietary Chinese Medicines are further improved and raised. Part I of the 2020 Edition of the Chinese Pharmacopoeia included over 60 Proprietary Chinese Medicines using aconitine-type alkaloids or strychnine-type alkaloids as ingredients. Due to the difficulty in obtaining reference images after the Ministry of Public Security stopped issuing them, the implementation of standards became problematic. To solve this, the 2025 Edition of the Chinese Pharmacopoeia conducted substitution research—using aconitine-type alkaloids and strychnine-type alkaloids to replace the detection methods for Aconite Root and Strychnos seeds as ingredients in preparations. Revisions and drafting were completed for 57 varieties.

1.3.4 Harmonization of Post-Market Changes with National Drug Standards

The 2025 Edition of the Chinese Pharmacopoeia, in accordance with regulations concerning post-market changes in Chinese medicine, carried out revisions to Pharmacopoeia standard content to ensure harmonization between post-market changes for varieties and national drug standards. For example, the Guizhi Fuling Granules were revised based on post-market changes, including adjusting the relative density of the immersion paste, adding steps to combine granules, increasing the density of the granules, and revising content such as the type of excipients, dosage form, preparation process, specifications, and limits for the physical and chemical characteristics caused by changes in the formulation process. The Pharmacopoeia synchronized the revision of items such as preparation process, characteristics, and limits.

1.3.5 Exploring the Formulation of Upper and Lower Limits for Content

While the content determination of Proprietary Chinese Medicines generally only requires a lower limit, the establishment of both upper and lower limits is important for ensuring the safety and guaranteed consistency of medication. In the 2025 Edition of the Chinese Pharmacopoeia, considering that other statins in preparations containing blood lipids-lowering statins have been identified as active ingredients that are both hepatotoxic and neurotoxic [2], the standards explore the formulation of upper and lower limits for statin content to further ensure drug safety.

1.3.6 Strengthening the Overall Control of Standards

Due to the complexity of Chinese medicine components, and in order to comprehensively control the stability and effectiveness of Chinese medicine quality, the 2025 Edition of the Chinese Pharmacopoeia continues to strengthen the overall quality control of Chinese medicine, controlling multiple components. Methods for overall control, such as adding fingerprints or characteristic chromatograms and multi-index content determination, have been added to several varieties, including Xiaochaihu Granules (Minor Bupleurum Granules), Juhong Tanke Oral Liquid (Tangerine Peel Phlegm-Cough Oral Liquid), and Compound Salvia Drop Pills.

2. Features of the 2025 Edition of the Chinese Pharmacopoeia (Volume I)

2.1 Steady Improvement in Chinese Medicine Safety Control

The 2025 Edition of the Chinese Pharmacopoeia further improves the control of exogenous harmful substances. Based on expanding the variety of banned pesticides and limits requirements, the edition has formulated limit standards for pesticides used in medicinal materials for the first time, perfecting the Chinese medicine pesticide residue standard system. It has also formulated detection methods and limits for plant growth regulator residues in botanical Chinese medicines for the first time, providing a reference for the formulation of similar standards in the future.

Regarding the limit standards for heavy metals and harmful elements, limit standards are formulated for medicinal materials and decoction pieces according to different risk levels. For varieties with relatively high compliance, heavy metal and harmful element limits can be included in the general chapters, reducing the burden on enterprises by waiving batch-by-batch inspection when adequate traceability is ensured; for varieties with relatively low compliance, relevant inspection items are included in the monographs, requiring batch-by-batch inspection to ensure medication safety.

The 2025 Edition of the Chinese Pharmacopoeia has also launched dedicated research on endogenous toxic and harmful substances, establishing research guidelines for the use of reference standards to replace the toxic components in Aconite Root and Strychnos seeds.

After multiple revisions, the current level of safety control for Chinese medicine in China is on par with international standards, and some projects have already reached a level that leads international plant medicine standards.

2.2 Chinese Medicine Standards are More Scientific and Rigorous

First, the consistency of standards is further improved. Decoction pieces are important raw materials for clinical compounding and the production of proprietary Chinese medicines, but their quality control items have historically been missing or incomplete compared to medicinal material standards. The 2025 Edition of the Chinese Pharmacopoeia improves the quality of decoction piece standards by adding the five quality control items (characteristics, impurities, moisture, ash, and extractives), while enhancing the coordination between medicinal material and decoction piece standards.

Second, it is problem-oriented, further improving the applicability and practicality of medicines. The 2025 Edition addresses issues such as the disconnect between the actual situation of medicinal materials and decoction pieces, and unreasonable limit settings in some standards. It scientifically adjusts the limits of relevant detection items based on specialized research results and issues found during drug regulatory work, improving the standards for proprietary Chinese medicines.

Third, the specificity is further enhanced. By revising inspection items, microscopic identification, and content determination items for related components, the specificity of Chinese medicine standards is further strengthened.

Fourth, more attention is paid to the holistic quality control of Chinese medicine, using detection techniques like fingerprinting and characteristic mapping, to achieve overall control of the main chemical components.

2.3 The Chinese Medicine Standard Formation Mechanism is Further Improved

The 2025 Edition of the Chinese Pharmacopoeia actively explores and perfects the national standard formation mechanism for Chinese medicine, striving to establish a drug standard working pattern characterized by “government leadership, enterprise primary responsibility, and social participation.”

First, during the pharmacopoeia compilation process, in-depth research is carried out with industry associations, manufacturers, medical institutions, universities, and research institutions to collect opinions from all sectors of society.

Second, the management of national drug standard projects is strengthened, introducing a competition mechanism, and openly and preferentially selecting project undertaking units. The disclosure of project initiation, drafting, and review information is deepened to ensure the openness, fairness, and impartiality of the standard work.

Third, the mechanism for social forces, such as Market Authorization Holders (MAHs) and research institutes, to directly apply for revision of Chinese Pharmacopoeia standards is further strengthened, and the standard formation mechanism is improved. For example, the newly added or revised proprietary Chinese medicines in the 2025 Edition, such as Glechoma Extract Capsules and Cassia Twig, Poria and Moutan Bark Pills, are all results of social forces applying to carry out standard research according to the requirements of the national drug standard revision technology.

2.4 The Chinese Herbal Decoction Pieces Standard System is Further Improved

Chinese herbal decoction pieces are products of Chinese medicinal materials after processing, which can be directly used for clinical application in TCM or for the production of preparations [10]. Whether the processing is standardized directly affects the quality of Chinese medicine and the safety of clinical use.

According to the Drug Administration Law of the People’s Republic of China, Chinese herbal decoction pieces should be processed according to national drug standards; where there are no national drug standards, they should be processed according to the processing specifications formulated by the competent administrative departments of provinces, autonomous regions, or centrally-administered municipalities. The decoction pieces included in the Chinese Pharmacopoeia are generally used widely nationwide; the processing specifications of provinces or autonomous regions or the locally used decoction pieces are a supplement to the national drug standards.

Currently, 30 provincial administrative regions implement decoction piece processing specifications, but the specifications are not uniform across regions, leading to differences in compilation systems, item settings, control levels, revision frequency, and problems like “different names for the same substance,” which may affect the quality of decoction pieces. To establish a sound decoction piece standard system and promote the standardization of production, the Pharmacopoeia Commission, in accordance with relevant regulations, formulated the National Processing Specifications, which, along with the Chinese Pharmacopoeia, are mutually complementary in their scope and implementation [6].

2.5 Adjusting Pharmacopoeia Varieties Guided by Clinical Needs

The adjustments to variety additions and delistings in the 2025 Edition of the Chinese Pharmacopoeia are more focused on clinical needs.

First, regarding variety additions, the selection principles are consistent with the current Pharmacopoeia, focusing on varieties that are clinically commonly used, safe, effective, controllable in quality, and have reasonable dosage forms, continuously expanding the coverage of essential medicines and the medical insurance catalogue, and adjusting the specifications of decoction pieces based on changes in TCM clinical needs.

Second, regarding variety delisting, the 2025 Edition of the Chinese Pharmacopoeia actively explores and perfects the delisting mechanism, for the first time no longer including varieties that have not been used clinically for a long time or do not have an approval number.

3. Conclusion

The 2025 Edition of the Chinese Pharmacopoeia (Part I) is guided by the needs of TCM clinical practice and focuses on enhancing the safety and assurance level of Chinese medicine, improving the overall control level of Chinese medicine standards, perfecting the system of standards for Chinese herbal decoction pieces, and improving the mechanism for standard formation. It plays a vital role in strengthening support services for drug regulation, promoting the development of the TCM cause, ensuring public medication safety, and safeguarding public health.

Since the 1963 edition of the Chinese Pharmacopoeia first separated TCM standards from chemical drug standards, TCM standards have been continuously improved and elevated. From the initial inclusion of content like “pills, powders, plasters, elixirs” to the current establishment of comprehensive quality standards covering aspects such as “source, characteristics, identification, inspection, fingerprinting, characteristic mapping, content determination, processing, nature, flavor, meridians, functions and indications, usage and dosage, precautions, and contraindications,” the Pharmacopoeia continues to shoulder the responsibility of guaranteeing the major quality standard system. The specificity, stability, and accuracy of the standards are constantly improving, moving from traditional experiential identification to the use of modern mature analytical technology. However, due to the complexity of Chinese medicine components and the inability of scientific research to completely elucidate the mechanism of action, Chinese medicine standards are the result of the combined action of the current level of cognitive understanding, scientific and technological testing capabilities, industrial development needs, and public medication needs. With the deepening of scientific technology related to TCM, the standards of the Chinese Pharmacopoeia must also be continuously improved and perfected, establishing that the “most rigorous standard” is always on the way.

Source: China Association of Traditional Chinese Medicine