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The HMPC/MLWP decided to prepare a Community herbal monograph on Allium cepa L., bulbus as announced in the meeting report from the January 2010 HMPC meeting.
After reviewing information on the products containing Allium cepa L., bulbus and preparations thereof marketed in the Community, it appears that very few products (single-ingredient and combination) are available.
A comprehensive literature search was conducted and available data, including information on products on the market in the Community, are assessed vis-à-vis the requirements laid down in Directive 2001/83/EC and its Annex I, in particular Article 1, Article 10a and Chapter 2a.
The HMPC/MLWP concluded that the following requirements for the establishment of a Community herbal monograph on traditional and well-established herbal medicinal products containing Allium cepa L., bulbus are not fulfilled:
- the requirement laid down in Article 10a of Directive 2001/83/EC that the active substance has a recognised efficacy and an acceptable level of safety and that the period of well-established medicinal use has elapsed
- the requirement laid down in Article 16a(1)(d) of Directive 2001/83/EC that “the period of traditional use as laid down on Article 16c(1)(c) has elapsed”

Based on the above-mentioned information, the HMPC is of the opinion that a Community herbal monograph on Allium cepa L., bulbus cannot be established.
To read more about the assessment carried out, a link is provided to the page where to access the draft assessment report on Allium cepa L., bulbus and its list of references.

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch, radix (liquorice root)
i) Herbal substance Not applicable.
ii) Herbal preparations

a) Comminuted herbal substance

b) Soft extract (DER 1:0.4-0.5), extraction solvent water

c) Soft extract (DER 3:1), extraction solvent water

Comminuted herbal substance as a herbal tea for oral use.
Herbal preparations in liquid dosage forms for oral use.
The pharmaceutical form should be described by the European Pharmacopoeia full standard term.

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Symphytum officinale L., radix (comfrey root)
i) Herbal substance Not applicable.
ii) Herbal preparations Liquid extract (DER 2:1), extraction solvent ethanol 65% V/V.

Herbal preparations in semi-solid dosage forms for cutaneous use.
The pharmaceutical form should be described by the European Pharmacopoeia full standard term.

Traditional herbal medicinal product used for the symptomatic treatment of minor sprains and bruises.
The product is a traditional herbal medicinal product for use in the specified indication

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Fraxinus excelsior L. and Fraxinus angustifolia Vahl, folium (ash leaf)
i) Herbal substance
Not applicable.
ii) Herbal preparations
Comminuted herbal substance

Comminuted herbal substance as herbal tea (decoction or infusion) for oral use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term.

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The European Medicines Agency’s (EMA) qualification process is a new, voluntary, scientific pathway leading to either a CHMP opinion or a Scientific Advice of novel methodologies on innovative methods or drug development tools. It includes qualification of biomarkers developed by consortia, networks, public/private partnerships, learned societies or pharmaceutical industry for a specific intended use in pharmaceutical research and development.
The Qualification team was: Prof. Fernando de Andrés Trelles (coordinator), Prof. Luca Pani (CHMP member), Dr Bertil Jonsson. The EMA Scientific Administrator for the procedure was Dr Maria Isaac.
On 23 March 2011 the Applicant C-Path CAMD Biomarker Working Group requested qualification advice for the Candidate Biomarkers of Alzheimer’s Disease (AD).
The procedure started during the SAWP meeting held on 26 – 28 April 2011.
The discussion meeting with the Applicant took place on 29 June 2011.
During its meeting held on 30 August – 01 September 2011, the SAWP agreed on the advice to be given to the Applicant. During its meeting held on 19 – 22 September 2011, the CHMP adopted the advice to be given to the Applicant. This advice is annexed to this letter.
The response given by CHMP is based on the questions and supporting documentation submitted by the Applicant, considered in the light of the current state-of-the-art in the relevant scientific fields.
The present opinion addresses the question as to whether the use of baseline measurement of low hippocampal volume (atrophy) by MRI are qualified in selecting (i.e. to categorize) subjects for trials in early Alzheimer’s Disease (AD) as having a high probability of being in the prodromal stage of the disease as defined by the Dubois Criteria (2007).
The vast majority of the data used in CHMP’s evaluation have been submitted by CAMD, the applicant that requested the qualification, and are all published literature available in the public domain. They have been supplemented by further information searched required by members of the qualification team.

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The Agency acknowledges that copies of the underlying works used to produce this monograph were provided for research only with exclusion of any commercial purpose.
Allen DE, Hatfield G. Medicinal plants in folk tradition. Timber Press, Portland, Cambridge 2004, 111-112
Amenta R, Camarda L, Di Stefano V, Lentini F, Venza F. Traditional medicine as a source of new therapeutic agents against psoriasis. Fitoterapia 2000, 71:13-120
Bandyukova VA, Sergeeva N. Rutin in some cultivated plants. Khimia Prirododnich Soedinieni 1974, 4:524
Baszyński T. Zawartość tokoferoli (witaminy E) w kwiatach roślin łąkowych. Roczniki Nauk Rolniczych 1961, 74:757-762
Behmanesh Y, Abdollahi M. Haemolysis after consumption of Viola tricolor. WHO Drug Information 2002, 16:15-16
Bobowska M, Gobiec K, Grzęda W, Kempisty J, Sadowski Z. Poradnik Terapeutyczny. PZWL, Warszawa 1975, 408-409
Boruch T, Góra J, Bielawska M, Świątek L, Łuczak S. Extract of plants and their cosmetic application. Part XI. Extract from herb of Viola tricolor. Pollena: TSPK 1985, 82:38-40
Bradley PR. editor.Heartsease. Violae tricoloris herba. British Herbal Compendium. Vol 2. British Herbal Medicine Association, Bornemouth 2006, 207-210
Braun H. Heilpflanzen-Lexikon fűr Ärzte und Apotheker. Viola tricolor. Feldstiefmütterchen. Gustav Fischer Verlag, Stuttgart 1974, 197
Brinker F. Herb contraindications and drug interactions. Appendix A. Herbs to be used with caution. Eclectic Medical Publications 2001, 209-211….

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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The herbal substance of wild pansy and/or European field pansy is mentioned in several well known handbooks such as Madaus (1938), Martindale (2007), Wichtl (1994; 2004), PDR for Herbal Medicines (2000; 2004), German Commission E Monograph, European Pharmacopoeia 6.0, Duke’s Handbook of Medicinal Herbs (2002), Hänsel et al. (1994) and Chevallier Encyclopedia of Medicinal Plants (1996).
In the European Pharmacopoeia it is described as the dried flowering aerial parts of Viola tricolor L. (wild pansy) and/or spp. Viola arvensis Murray (Gaud.) and Koch (Oborny) (European field pansy). Wild pansy must contain at least 1.5 percent of flavonoids, calculated with reference to the dried substance, expressed as violanthin.
Wild pansy belongs to the family of Violaceae. The herb is distributed in Europe and Asia. Flowering aerial parts of wild pansy are harvested during summer.

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This procedure has been prepared to clarify the conditions when the Committee on Herbal Medicinal Products (HMPC) shall establish a public statement on an herbal substance which was on the HMPC priority list, in the situation where it does not establish a Community herbal monograph on that herbal substance and preparations thereof.
The publication of this procedure is part of the European Medicines Agency’s initiatives to improve transparency in the regulatory and scientific processes followed by the HMPC in fulfilling its tasks as defined by the European legislation.

This procedure does not address the situations where:
a Community list entry cannot be established
a herbal preparation is not included in a Community herbal monograph
The justification as to why a Community list entry cannot be established together with the relevant Community herbal monograph can be found in the assessment report (AR). For the assessment works carried out so far which had led to the publication of final monographs, the absence of adequate genotoxicity data, as part of the evidence required to demonstrate a safe use, has been the primary justification to the non-establishment of a Community list entry on a herbal substance and/or preparations thereof.
The justification as to why a given herbal preparation is not included in a monograph can be found in the AR and/or in the ‘Overview of comments received during the public consultation’. It cannot be expected that such a justification is available for every possible preparation. Current practice is that justification is provided for preparations which can be found on the market of one or several Member States of the European Union and made known to the Rapporteur either by members of the HMPC/Working Party on Community Monographs and Community List (MLWP) or by interested parties via their comments on draft monographs.

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In accordance with Directive 2001/83/EC amended as regards traditional herbal medicinal products through Directive 2004/24/EC (1), it is the task of the Committee on Herbal Medicinal Products (HMPC) to establish a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (Article 16f). Furthermore, the HMPC shall establish Community herbal monographs for herbal medicinal products (Article 16h(3)). The HMPC has also undertaken to ensure that monographs and list entries remain up-to-date (scientific state of the art) by assessing regularly the need for their revision (5, 6).
The legislation does not specify how scientific data relating to the assessment work for the monographs and list entries should be identified and compiled. The HMPC discussed a number of possibilities and agreed on a practice subject to 3 conditions:
1. The compilation of data will be a public procedure; and
2. The compilation will take place within a framework of criteria to be predefined by the HMPC (e.g. in relation to literature search strategy); and
3. The compilation shall seek to ensure that a complete set of bibliographic references and/or scientific data will be available to the Rapporteur(s).

No requirements for scientific standards are provided in the legislation and submission by interested parties of bibliographic references and/or scientific data is voluntary. However, some guidance as to the scope of data requested can be provided through the application of Directive 2001/83/EC:
Bibliographic data submitted in relation to well-established medicinal use should provide evidence that the constituent or the constituents of the medicinal product has or have a well-established medicinal use with recognised efficacy and an acceptable level of safety within the meaning of Directive 2001/83/EC as amended (Recital 2 of Directive 2004/24/EC).
Bibliographic data submitted in relation to traditional-use should provide evidence that the medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the Community (Article 16c(1)(c)).
In addition, the contributor is expected to submit both favorable and unfavorable data as well as to ensure that the newest publications are taken into account.
Further guidance on the requirements can be found in the HMPC ‘Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (bibliographical and mixed applications) and in applications for simplified registration’ (2) and the HMPC ‘Guideline on the assessment of clinical safety and efficacy in the preparation of Community herbal monographs for well-established and of Community herbal monographs/entries to the Community list for traditional herbal medicinal products/substances/preparations’ (3).

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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