What is herbal pharmacopoeia
Monographs as a guideline
The ESCOP has established a scientific committee that creates, discusses and finally approves the drafts of the monographs. The monographs refer to herbal medicinal products, which are defined in the European Pharmacopoeia, and aim to compile the relevant literature on these medicinal products. An evaluation is made on the basis of the selected references; The reproduction of poorly conducted studies and examinations with major deficiencies was dispensed with. In addition, the information is not further evaluated or processed, but only reproduced.
The ESCOP monographs are not an official collection that defines a legal standard. They are a scientifically oriented, little judgmental compilation of data that reflects the perspectives and interests of the national societies for phytotherapy. For the pharmacist, they provide the scientific background on medicinal drugs.
The Committee on Herbal Medicinal Products (HMPC) was set up at the European Medicines Agency (EMA, London) in 2004 on the basis of a European regulation. The HMPC is one of a total of seven scientific committees of the EMA and underlines the importance that the European Parliament assigns to the harmonization of the evaluation of herbal medicinal products and their availability in the European Union.
The committee consists of a specialist representative appointed by each member state (employees of the national authorities or experts from the universities) as well as five co-opted members who represent special topics. Currently these are, for example, general medicine, pediatrics, pharmacology and toxicology.
The most important task of the HMPC is the creation of community monographs in which the information on the efficacy and safety of herbal medicinal products and their preparations are summarized after a critical assessment. The HMPC monographs contain the current state of scientific knowledge from a regulatory point of view. The national authorities of the EU member states should use them as a basis when evaluating applications for authorization of herbal medicinal products or the registration of traditional herbal medicinal products. The monographs are not directly binding, but are legally interpreted as recommendations from which the national authorities should only deviate if specifically justified. If the available data material is particularly extensive and fully complies with the requirements of Directive 2004/24 EC, a »list item« can also be created for registration as a traditional herbal medicinal product. Its structure is comparable to a monograph, but is finally accepted by the European Commission and is then binding in all member states.
The structure of the HMPC monographs is also based on specialist information. However, there are two categories that depend on the importance of the evidence.
→ Well-established use
The prerequisite is medical use as a medicinal product in an EU country with sufficient bibliographic documentation and accepted and professionally recognized data for at least ten years. From the point of view of the HMPC, at least one good clinical study is required for assignment to this category. In the case of heterogeneous data, the available findings must be taken into account in their entirety.
→ Traditional use
With Directive 2004/24 / EC, the EU made it possible to register traditional herbal medicinal products in a simplified procedure. The evidence of effectiveness and harmlessness is based primarily on a tradition of at least 30 years of medical use, of which at least 15 years in an EU country. Various specifications, for example the restriction of the type of application to oral or external use or inhalation as well as safe use in self-medication, are intended to ensure the harmlessness of traditional herbal medicinal products.
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