Herbal Monographs: Commission E, EMA/HMPC, WHO and Pharmacopoeias

A monograph is an official write-up about one herbal substance. Different bodies write different kinds. Some describe approved medicinal uses and safety information, and some set quality standards for the plant material. A monograph is written for regulators, manufacturers and health professionals, not as personal advice. This page explains the main kinds, quotes what monographs say only as the source states it, and notes where we could not read a source.

The main kinds

EU monographs: two kinds of use

The HMPC prepares opinions on herbal substances and preparations, along with information on recommended uses and safe conditions. [5] EU monographs have two sections:

• Well-established use. Demonstrated with sufficient safety and efficacy data. [1] EMA's herbal medicines page describes this as well-established medicinal use within the EU for at least ten years. [2]
• Traditional use. Accepted on the basis of sufficient safety data and plausible efficacy. [1] For registration, products must have been used for at least 30 years, including at least 15 years within the EU. [2]

Each preparation is assessed individually, so some preparations appear in one section and others in the other. [1] Member States are not obliged to follow a monograph. [1] These rules concern authorised herbal medicines. EMA states that food, food supplements and cosmetics do not follow the same criteria and regulatory requirements. [6]

Examples, quoted as the monographs state them

These are statements about authorised medicinal products, not teas, foods or supplements. Statements also differ between bodies. The EMA ginger summary says not to use ginger medicines if pregnant or breastfeeding, [6] while NCCIH says the use of ginger dietary supplements during pregnancy may be safe, and advises asking a health care provider. [8] A reader with questions about a specific situation should ask a pharmacist or clinician.

The HMPC also published a public statement on prioritisation for herbal substances associated with safety concerns. It says detailed assessments of the substances listed are not a priority because a monograph is foreseen to be impossible, owing to a likely unfavourable benefit-risk assessment. [9]

Commission E and pharmacopoeias

Commission E. Proper evidence not found, in the sources we read, for a description of what the German Commission E was, how many monographs it issued or its present status. We searched PubMed, Europe PMC and the EMA and WHO sites. What we found were indirect mentions:

• A study of ginkgo products said many referred to the German Commission E monograph (of the Federal Institute for Drugs and Medicinal Devices) and did not match its specification. [10]
• A 2026 study reports a 1984 German Commission E decision to restrict all internal use of arnica. [11] The arnica page covers its safety.

Pharmacopoeias. The same ginkgo study mentions a pharmacopoeial monograph for ginkgo extract in Germany that standardizes the content of relevant substances. [10] We could not read the European Pharmacopoeia, the U.S. Pharmacopeia or Health Canada monographs this session, so we do not describe them.

Limits

• A monograph does not tell a person what to take. Amounts in monographs belong to approved medicinal products and are not repeated here.
• Researchers note that there is no clear method for compiling and assessing evidence of traditional use. [11]

For regulation and traditions, see European herbal tradition and monographs, traditional herbal medicinal products registration, EU herbal monographs explained and pharmacopoeias and herbal monographs. For medicines and pregnancy, see the medicine interactions guide.