HMPC monographs

HMPC is the acronym for Committee onHerbalMedicinalProducts. This committee 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 attaches to the harmonisation of the evaluation of herbal medicinal products and their availability in the European Union.

The main task of the HMPC is to produce Community monographs summarising the efficacy and safety data of herbal medicinal drugs and their preparations after critical evaluation.

From a regulatory point of view, the HMPC monographs contain the current state of scientific knowledge. The national authorities of the EU Member States are to use these monographs as a basis for the evaluation of applications for marketing authorisation of herbal medicinal products or registration of traditional herbal medicinal products. The monographs are not directly binding, but are legally interpreted as recommendations from which national authorities should only deviate with specific justification.

If the available data material is particularly extensive and fully meets the requirements of Directive 2004/24 EC, a "list item" can also be prepared - for registration as a traditional herbal medicinal product. This is similar in structure to a monograph, but is finally adopted by the European Commission and is then binding in all member states.

Structure of an HMPC monograph: The HMPC monographs follow the structure of a pharmacopoeial summary. However, there are two categories depending on the importance of the evidence.

Well-established use: The prerequisite for this label is at least ten years of medical use as a medicinal product in an EU country with sufficient bibliographic documentation as well as accepted and professionally recognised data. 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 evidence should be considered in its entirety.

Traditional use: Directive 2004/24/EC opened up the possibility in the EU to register traditional herbal medicinal products in a simplified procedure. The proof of efficacy and safety is mainly based on at least 30 years of tradition of medicinal use, of which at least 15 years in an EU country. The safety of traditional herbal medicinal products is to be ensured through various requirements, for example the restriction of the type of application to oral or external use or inhalation, as well as safe use in self-medication.

Contents of HMPC monographs: In the HMPC monographs, the following sections are included for Well-established use and Traditional use in two columns side by side:

• Name of the monograph
• Qualitative and quantitative data, overview of the preparations
• Pharmaceutical form
• Clinical properties: indications for use, dosage and route of administration, duration of use, contra-indications, precautions and warnings, interactions, pregnancy, lactation, fertility, effects on driving ability, adverse drug reactions, overdose.
• Pharmacological properties: pharmacodynamic properties, pharmacokinetic properties, preclinical safety data
• Pharmacological properties (if relevant): For Traditional use, the information on pharmacological properties may be omitted completely.

The HMPC had adopted about 120 monographs by early 2014(www.ema.europa.eu; selection field "find medicine"; selection field "herbal medicine"). Only about one-fifth were considered to meet the well-established use criteria. If the data available for different preparations of a drug are inconsistent, different forms of preparation may be classified once as well-established use and once as traditional use. Only two monographs deal with combinations of two herbal medicinal drugs. To date, only twelve list items have been submitted to the European Commission, all of which have been accepted. If the evaluation cannot be concluded positively, this will be communicated in a "Public Statement". This may be the case if there are risks, precise information on dosage is missing or the basis for a 30-year tradition does not exist.

Thepreparation of HMPC monographs is a transparent process: on average, the HMPC adopts about 20 new monographs each year. The preparation of HMPC monographs is based on publicly available scientific data. The monograph production starts with a public call for technical data for the herbal medicinal drug in question. Member States prepare a survey of the medicinal products available in their market. The nominated rapporteur conducts a literature search and prepares a draft based on all data, which is discussed in the MLWP (Working Party on Monographs and List Entries), a working group of the HMPC. In this process, the available technical literature is not only compiled, but critically assessed - also taking into account the current state of scientific knowledge and regulatory requirements. This scientific assessment is recorded in an assessment report.

Once the draft has been approved by the HMPC, it is published on the EMA website for public comment. The comments submitted will be summarised in a review document, discussed in the MLWP and may also lead to an amendment of the draft. Finally, the monograph, the assessment report, the overview of comments and a list of references are finally adopted by the HMPC and published on the EMA website.

The HMPC has established a process by which monographs are regularly revised at five-year intervals and brought back into line with current scientific knowledge. New studies and findings are incorporated in the process. The HMPC monographsrepresent an official regulatory standard for all EU member states . The harmonisation of the assessment based on very different traditions in the individual member states certainly leads to restrictions. In many cases, the HMPC monographs do not provide for any or only limited use in children or adolescents. The HMPC monographs, together with the accompanying documents, are publicly available free of charge. They are thus available not only to regulatory authorities, but also to scientists, physicians and pharmacists, as well as the general public.