The Chinese Pharmacopoeia and Quality Standards for Herbs
What the Chinese Pharmacopoeia is, how it covers herbs and patent medicines, how it compares with European standards, and what standards cannot guarantee about a product you buy.
Content last updated . This page has not been medically reviewed.
What a pharmacopoeia is
A pharmacopoeia is an official book of quality standards for medicines. The Chinese Pharmacopoeia (ChP) is a drug code formulated by the Chinese government. [1] It sets monographs, which are entries that say how a herb or product is identified and tested. In China, it is also described as the legal basis that must be strictly followed in drug development, production, operation, application and management. [2] This page explains the standard in general terms. It is not a guide to buying or using any herb.A short history
The first edition was published in 1953 and did not yet contain traditional Chinese medicines. [1] The second edition in 1963 included 643 TCM monographs for the first time in Volume I, and Volume I has been the special volume for TCM since. [1] After the fourth edition in 1985 the ChP has been released every five years. [1] The 2020 edition was implemented at the end of 2020. [1]What is in it
The 2020 edition records 2,711 monographs of Chinese materia medica, covering herbal drugs and animal-sourced and mineral-sourced materials. [3] In the 2015 edition, Volume I was divided into three parts: medicinal materials and prepared slices, oils, fats and extracts, and Chinese patent drugs with single-herb preparations. [1] The ChP also has a general principle for processed herbal drugs, because many herbs are processed (for example by steaming or stir-frying) before use. [3] For patent medicines, the 2020 edition describes preparation from decoction pieces to finished products in detail. [2]How quality is tested
Chromatography is the main analytical method in the ChP, used to assess the overall quality of TCM, which is chemically diverse. [1] Fingerprint-style tests, which compare a pattern of compounds, appeared in more than 30 monographs in the 2015 edition. [1] The ChP also sets limits for specific contaminants. In the 2020 edition, 16 herbal drugs must be tested for aflatoxins. [3] Pesticide limits are recorded too: 33 in the ChP compared with 69 in the European Pharmacopoeia. [3]Other standards
Different regions keep their own standards. Examples named in one review include the Hong Kong Chinese Materia Medica Standards and the American Herbal Pharmacopoeia. [3] In Europe, Chinese herbal drug monographs have been developed since 2009 by a TCM working party in the European Pharmacopoeia, which does not elaborate animal-sourced or mineral-sourced materials. [3] Herbal drugs containing aristolochic acids are forbidden in herbal medicinal products in the EU. [3]| Question | What the source found | Strength of evidence |
|---|---|---|
| Do standards reduce risk? | They set tests and limits, but a standard on paper does not prove a product on a shelf meets it. Proper evidence not found on compliance rates in the sources we read. | Insufficient evidence |
| Are all standards the same? | No. The ChP and the European Pharmacopoeia differ in number of pesticide limits and in which materials they cover. [3] | Documented difference |
What standards cannot guarantee
Meeting a pharmacopoeia is one safeguard, not a promise. NCCIH notes that Chinese herbal products have been contaminated, and herbs have been mistakenly replaced with others. [4] The US FDA says aristolochic acid is a potent carcinogen and nephrotoxin and has an import alert on dietary supplement products containing it. [5] Standards do not tell you whether an herb is right for your health condition, or safe with your medicines.Animal and mineral materials raise extra safety and ethical questions; see Animal and Mineral Ingredients in Traditional Chinese Medicine.
Using this knowledge
You cannot read a pharmacopoeia and judge a product yourself. Use it to ask better questions: which standard does this product claim to meet, and who tests it? See Reading a Chinese Patent Medicine Label and Chinese Herbal Medicine. Talk to a clinician or pharmacist before using any herbal product, especially if you are pregnant, nursing, treating a child or taking prescribed medicine. NCCIH advises the same. [4]Frequently asked questions
What is the Chinese Pharmacopoeia?
The official drug code formulated by the Chinese government. [1] It includes a special volume for TCM monographs.
When was TCM first included?
643 TCM monographs were first included in the second edition, published in 1963. [1]
Does a pharmacopoeia mean a product is safe?
No. It sets quality tests, but contamination and substitution have still been reported in Chinese herbal products. [4]
Is the Chinese Pharmacopoeia used outside China?
Not as a legal standard everywhere. Europe has its own pharmacopoeia with TCM monographs, and other regions have their own standards. [3]
Where can I check a specific herb monograph?
We could not read the Chinese Pharmacopoeia Commission's own site this session, so we cannot link it. Ask a pharmacist or your national regulator.
References
- Shen MR, He Y, Shi SM. Development of chromatographic technologies for the quality control of Traditional Chinese Medicine in the Chinese Pharmacopoeia. J Pharm Anal 2021. Read 2026-10-22.
- Yin XB, et al. Preparation regularity of Chinese patent medicine in Chinese Pharmacopoeia (2020 edition, Vol. I). Zhongguo Zhong Yao Za Zhi 2022. Read 2026-10-22.
- Wang M, et al. Key quality factors for Chinese herbal medicines entering the EU market. Chin Med 2022. Read 2026-10-22.
- National Center for Complementary and Integrative Health. Traditional Chinese Medicine: What You Need To Know. Read 2026-10-22.
- U.S. Food and Drug Administration. Import Alert 54-10: Detention without physical examination of bulk/finished dietary supplements products containing aristolochic acid. Read 2026-10-22.
Education, not medical advice. This page is for general information. It does not diagnose or treat any condition and is not a substitute for care from a qualified health professional. Natural does not automatically mean safe. Ask a clinician or pharmacist before changing your care, especially if you take medication, are pregnant or breastfeeding, or have a health condition.