Pharmacopoeias and Herbal Monographs: WHO, EMA and National Standards

What these documents are

A pharmacopoeia is an official book of quality standards for medicines and their ingredients. A monograph is a single entry: for an herb, it names the plant material and sets out how to confirm that it is the right plant and meets quality limits. Some monographs also summarize safety and use. Different organizations write different kinds, and the difference matters when a label says "meets monograph standards."

This page covers the sources read for this site: the European Medicines Agency (EMA), the British Pharmacopoeia, WHO, and one mention of the Japanese Pharmacopoeia. Other countries have their own pharmacopoeias, which are not described here.

European Union herbal monographs

The EMA's Committee on Herbal Medicinal Products (HMPC) prepares EU herbal monographs. An EU monograph contains the committee's scientific opinion on safety and efficacy data about a herbal substance and its preparations intended for medicinal use. [1] The committee looks at non-clinical and clinical data and also at documented long-standing use. [1]

Each monograph has two kinds of entry, and the difference is important for how to read them:

For traditional-use registration, the EU requires use for at least 30 years, including at least 15 within the EU. [2] Member States are not obliged to follow the monographs, though a decision not to accept one should be duly justified. [1] A separate EU "list entry" is legally binding on applicants and national authorities. [1]

The HMPC also cooperates with the European Directorate for the Quality of Medicines and Healthcare on European Pharmacopoeia standards. [3] So there are two layers: quality standards (is it the right plant, and is it clean?) and a scientific opinion on use. For the national picture in Europe see traditional herbal medicinal products in the EU.

The British Pharmacopoeia

In the UK, the British Pharmacopoeia Commission must prepare editions of the British Pharmacopoeia at intervals it thinks appropriate. [4] The Commission's 2025 report lists work on herbal monographs, including new extract monographs for green tea dry extract and decaffeinated green tea extract in the 2025 edition. [5] It also records an update to the chapter on DNA-based identification techniques. [5] That kind of testing is about confirming which plant is in a product, which matters because substitution of one botanical for another is a documented hazard. [6]

WHO monographs and collection guidelines

WHO published a volume titled WHO monographs on selected medicinal plants. [7] It also published guidelines on good agricultural and collection practices for medicinal plants in 2003, which address how plants are grown and harvested. [8] See WHO reports and guidance for WHO's wider work.

Japan

A review of Kampo research says quality control of purity and toxicity is standardized in Japan, following the Japanese Pharmacopoeia and international good manufacturing and laboratory practice rules. [9] Details are on the Kampo formulas page.

What a monograph does not do

• It does not make a product safe for everyone. Quality limits address identity and purity. They do not remove interaction, pregnancy or liver risks.
• A traditional-use monograph is not a trial result. The EU says traditional use is accepted on sufficient safety data and plausible efficacy. [1]
• It does not cover every product. In the US, FDA says it is not authorized to approve dietary supplements for safety and effectiveness before they are marketed. [10]
• A passing quality test does not remove contamination risk across the market. NCCIH says some Ayurvedic preparations may contain lead, mercury or arsenic in amounts that can be toxic. [11]

How to use this when shopping or asking questions

Ask which standard a label means: a national pharmacopoeia, an EU registration, or only the maker's own claim. Ask for the plant's Latin name, the part used and the extract. Read reading supplement labels and product quality and contamination. Tell your clinician or pharmacist about herbal products you use, especially with prescription medicines, pregnancy or children. [12]