Monographs

A monograph is a scientific work on a specific topic, usually written by one author. For example, a doctorate is a monograph. In pharmacy, monographs describe special entries in European and national pharmacopoeias.
Monographs are the result of cumulative knowledge on the one hand, and on the other hand they standardize the safe use of phytopharmaceuticals, for example. The monographs of the pharmacopoeias (European Pharmacopoeia, German Pharmacopoeia and, where applicable, the pharmacopoeias of other member states) set jointly developed and accepted standards for their quality.

In phytotherapy, monographs are used to declare recognized medical use. Drug monographsfrom HMPC, ESCOP, Commission E and WHO provide information on the scientific findings regarding the appearance, ingredients, effects, side effects, areas of application and dosage of a drug. Drug monographs define the quality requirements for a drug and the methods prescribed for quality testing in the European Pharmacopoeia (Ph. Eur.), the German Pharmacopoeia (DAB) and the German Drug Codex (DAC).E

Preparation of drug monographs: Commission E did this in Germany from 1983 to 1994 when the German Medicines Act (1978) came into force, ESCOP at European level from 1989 to the present day, the HMPC defines the recognized areas of application at European level as part of the approval of herbal medicinal products, and the WHO prepares plant monographs worldwide.

HMPC monographs are the primary source in Europe.

Commission E monographs (1984-1994) were important for the post-authorization of herbal medicinal products.

However, pharmacopoeias do not reflect the current state of knowledge on the efficacy and safety of herbal medicinal drugs. Various collections of monographs are available to experts for this purpose. The best known in Germany are the following monograph collections:

the monographs of Commission E

the WHO monographs

the ESCOP monographs

the HMPC monographs.

For a long time, the Commission E monographs were the official standard in Germany and were recognized and respected worldwide. Since these texts have not been revised since 1994, they have lost their relevance and importance.

HMPC mon ographs: The HMPC monographs(HMPC: Committee on Herbal Medicinal Products) are the new regulatory standard that is created on the basis of European legislation for the member states of the European Union (EU). Not only the summary in the form of monographs is available to experts and the public, but also the assessment reports and reference lists. This makes it possible to obtain information on the current state of scientific knowledge at any time.

WHO monographs: The monographs of the World Health Organization (WHO) and the ESCOP (European Scientific Cooperative on Phytotherapy) are not official collections. Nevertheless, they contribute to the international discussion and global understanding of the evaluation of herbal medicinal products. Compared to the official regulatory collections, WHO and ESCOP monographs sometimes contain divergent views and perspectives.

1. Knöss W et al. (2014) Legal framework conditions. Pharmakon focus issue: Complementary therapies. Pharmakon 2: 143-150.
2. https://arzneipflanzenlexikon.info/fachbegriffe.php