ESCOP Publications

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ESCOP Monographs and the ESCOP Scientific Committee

The Scientific Committee of ESCOP, comprised of delegates from each member country, embarked at the outset on a programme of compiling proposals for European Monographs summarising the medicinal uses of plant drugs (including their safety) - an area which ESCOP considers to be of prime importance for scientific harmonisation. 15 of these early monographs were published (5 in 1990, 10 in 1992) and submitted to the Committee for Proprietary Medicinal products (CPMP) for assessment.

On the advice of the CPMP the format of the Summary of Product Characteristics (SPC) was adopted for subsequent documentation. The SPC is an integral part of an application for authorisation to market a medicinal product for human use in any of the 15 Member States of the European Union, as laid down in Directive 65/65/EEC. According to the Notice to Applicants published in 1993, the SPC is a 'definitive statement between the competent authority and the marketing authorisation holder and it is the common basis of communication between the competent authorities of all the Member States'. Data sheets for medicinal products are based on the SPC, which is thus also the basis of information for the prescriber or supplier of the product.

Since November 1992, therefore, ESCOP Scientific Committee has been working on proposals for SPCs on individual plant drugs, primarily those for which European or national pharmacopoeial monographs exist. The sequence of topics in the SPC, as set out in Guideline 11/9163/89, is designed to highlight clinical aspects and, compared to the earlier ESCOP monographs, it is more demanding in terms of Pharmacological Properties - Pharmacodynamics, Pharmacokinetics and Preclinical Safety Data.

Although SPC proposals are being prepared for assessment by regulatory authorities, the summaries are also available for wider distribution as ESCOP Monographs. For this purpose the SPC format has been slightly amended (by omission of details relevant only to a product) while retaining all the scientific data on plant drugs in exactly the same sequence.

In preparing drafts, ESCOP Scientific Committee has the advantage that it can incorporate the views, knowledge and experience, not only of different nationalities, but also of individuals from different scientific and professional backgrounds, such as medical doctors, practising phytotherapists, pharmacognosists, pharmacologists and regulatory affairs specialists. The Committee, operating as two subcommittees, assesses information from published scientific literature on each plant drug with the assistance of leading researchers on specific plants, who are invited to meetings of the Committee for discussion and critical evaluation of the literature. We are indebted to these individual scientists, who have provided invaluable help to the work of ESCOP.

Drafts prepared by the subcommittees are then circulated to an independent Board of Supervising Editors for appraisal. These eminent academic experts in phytotherapy and medicinal plant research are invited to comment on and criticise each draft and, where appropriate, their comments are incorporated into the final version.

Thus each SPC proposal and ESCOP Monograph takes into account the available scientific literature, national viewpoints and the advice of many authorities on the subject.

ESCOP believes that the work of its Scientific Committee represents European harmonisation at its best and presents these monographs as an example of what can be achieved by cooperation among European scientists. It also acknowledges with gratitude financial support from the European Union through its BIOMED programme, which has made possible the intensive work of the Scientific Committee in recent years.

ESCOP MONOGRAPHS The Scientific Foundation for Herbal Medicinal Products Second edition Completely revised and expanded

This book marks a new authority on herbal medicine. Following the indispensable pioneering work of the Commission E in Germany, ESCOP has taken the lead role across Europe over the past decade in reviewing the therapeutic uses of herbal medicinal products. This is now recognized by the European Medicines Evaluation Agency, which formally receives ESCOP monographs as a basis for core dossiers on herbal medicines. Initial funding for the enterprise was provided by the European Commission.

ESCOP, representing national phytotherapy associations across Europe, is uniquely placed to provide an international consensus. Preparation of the monographs by the ESCOP Scientific Committee has involved delegates from 15 countries with the assistance of numerous external experts on herbal medicine and an eminent Board of Supervising Editors.

Sixty ESCOP monographs were published during the late 1990s. All have been updated and expanded, and this second edition includes a further twenty monographs. The text constitutes an up-to-date review of scientific information on the therapeutic uses of herbal medicines, including indications, dosage, contra-indications, interactions and undesirable effects, together with summaries of pharmacological, clinical and toxicological data. It is extensively referenced to scientific literature - almost 5000 full citations appear in the book.

ESCOP Chairman Professor Fritz H. Kemper has written

ESCOP is an organisation of volunteers. All members of the Scientific Committee, guest experts, the panel of Supervising Editors, and Board of ESCOP give their time freely to their work in pursuit of the highest standards for herbal medicinal products. This book really is a labour of love. We at the Board of ESCOP are very proud of the many who have contributed to these monographs and are most grateful to them.

The ESCOP monographs are an invaluable resource for health professionals, regulators, manufacturers and many others. They provide the evidence base for the clinical use of herbal medicinal products.

Click here for a list of the 80 monographs in ESCOP Monographs Second Edition 2003

Please see the bottom of this page for ordering information.

ESCOP MONOGRAPHS
The Scientific Foundation for Herbal Medicinal Products

Second edition  
Supplement 2009

The second edition of ESCOP Monographs published in 2003 achieved wide recognition for its authoritative information on the therapeutic uses of herbal medicines and summaries of pharmacological, clinical and toxicological data.

As part of ESCOP’s programme to expand and update the range of monographs the Supplement 2009 adds twenty-seven new ones to the eighty published in 2003, as well as eight monographs revised to include recent data from herbal research. Extensive references to scientific literature form an important part of each monograph and over 1800 new citations appear in the book.

The European legislative framework for herbal medicines has advanced considerably in recent years with the implementation of Directive 2004/24/EC, which introduced a simplified registration procedure for traditional herbal medicinal products in EU member states and imposed a 7-year deadline for the registration of certain products on the market.

In September 2004 the Committee on Herbal Medicinal Products (HMPC) was established as part of the European Medicines Agency. Among the HMPC’s core tasks are the preparation of Community Herbal Monographs, to provide a more harmonized approach to the scientific assessment of herbal medicinal products in the EU, and Community List entry documents pertaining to the safe use of herbal substances and preparations.

Whether the evaluation of a herbal medicine is based on evidence of clinical efficacy (well-established use) or on experience and historical use of that product in the European Community (traditional use) those involved at all levels of the regulatory process need access to detailed, reliable and structured summaries of the available efficacy and safety data. ESCOP monographs meet that requirement and offer an invaluable source of scientific information on herbal medicines to regulators, manufacturers, academics, researchers, health professionals and numerous others.

Professor Fritz H. Kemper, Chairman of the Board of ESCOP, wrote:

These are unique documents. ESCOP engages the expertise of many authorities. Our Scientific Committee and prestigious panel of Supervising Editors represent many Member States of the European Union, and additional experts also contribute to many of the texts. ESCOP monographs can truly be said to represent the best European knowledge base.

Ordering information

The Second Edition of ESCOP Monographs Supplement 2009 is published in association with Thieme, leading medical and scientific publishers with offices in Stuttgart and New York. Copies can therefore be obtained through booksellers and online retailers in the usual way.

Individual purchasers in the European Union or EFTA countries can also order directly from ESCOP.  
Order forms can be downloaded and faxed to the ESCOP office. 
Fax: + 44 1392 424 864.

Click here for an order form for ESCOP Monographs Second Edition 2003

Click here for an Order Form for Supplement 2009