DefinitionThis section has been translated automatically.
A monograph is a scientific work on a specific topic, usually written by one author. E.g. a doctorate is a monograph. In pharmacy, monographs describe specific entries in the European as well as in the national pharmacopoeias.
Monographs are on the one hand the result of cumulative knowledge, on the other hand they standardize the safe use of e.g. phytopharmaceuticals. For their quality, the monographs of the pharmacopoeias (European Pharmacopoeia, German Pharmacopoeia, if necessary also the pharmacopoeias of other member states) set jointly developed and accepted standards.
To define efficacy and safety of herbal medicinal products, the HMPC monographs are the primary source in Europe today.
General informationThis section has been translated automatically.
However, the pharmacopoeias do not reflect the state of knowledge on the efficacy and safety of herbal medicinal drugs. For this purpose, various monograph collections are available to the specialist community. The best known in Germany are the following monograph collections:
the monographs of Commission E
the WHOmonographs
the ESCOP monographs
the HMPC monographs.
For a long time, the Commission E monographs constituted the official standard valid in Germany, which was 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(HM PC: Committee on Herbal Medicinal Products) are the new regulatory standard, which is produced on the basis of European legislation for the member states of the European Union (EU). Not only the summary in the form of the monographs, but also the assessment reports and the reference lists are available to experts and the public. 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.
LiteratureThis section has been translated automatically.
- Knöss W et al. (2014) Legal framework. Pharmakon focus issue: complementary therapies. Pharmakon 2: 143-150.
