ESCOP monographs

The European Scientific Cooperative on Phytotherapy(ESCOP) is an umbrella organization of national societies for phytotherapy. The national societies delegate representatives from science, industry and interest groups to the ESCOP board. The organization was founded in 1989 to pool specialist knowledge and process published knowledge on herbal medicinal drugs. The ESCOP monographs are not an official collection that defines a legal standard. They are a scientifically oriented, only slightly judgmental compilation of data that reflects the perspectives and interests of the national societies for phytotherapy. For the dispensing pharmacist, they provide a scientific background to the medicinal drugs. The ESCOP monographs provide a basis for marketing authorization applications without being able to enforce them.

The ESCOP monographs are intended to compile the best available scientific evidence based on the current literature. At the same time, the data are also to be made available as knowledge material for the work of the CPMP (Committee for Proprietary Medicinal Products) . Even before the year 2000, a working group (Herbal Medicinal Products Working Group) of the CPMP compiled so-called core data on herbal medicinal drugs.

Contents of ESCOP monographs

The ESCOP monographs are designed to provide information on efficacy and safety. They are structured according to the structure of a SmPC in the following sections:

• Definition
• Ingredients
• Clinical data: indications for use, dosage, route and duration of use, contraindications, warnings and precautions, interactions, pregnancy and lactation, effects on driving ability, side effects, overdose
• Pharmacological properties: pharmacodynamic properties, pharmacological studies in humans
• Clinical studies
• Pharmacokinetic studies
• Preclinical safety data
• Clinical safety data
• References

ESCOP has established a scientific committee that prepares, discusses and finally approves the draft monographs. The monographs refer to herbal medicinal drugs defined in the European Pharmacopoeia and aim to compile the relevant literature on these medicinal drugs. An assessment is made on the basis of the selected references; poorly performed studies and studies with major flaws have not been reproduced. Furthermore, the information is not further evaluated or processed, but merely reproduced.

Thefirst ESCOP monograph was adopted in 1990. Since then, a total of 107 monographs have been completed and published. Since 2011, individual monographs have also been available as an online version(www.escop.com/monographs), which, like the printed edition, is subject to a charge.

1. Knöss W et al. (2014) Legal framework. Pharmakon focus issue: complementary therapies. Pharmakon 2: 143-150.