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ESCOP Publications 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.
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. 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. 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 list of 80 monographs in 2nd edition ESCOP book 2003 For details on ordering, please click here. Fascicules of ESCOP monographs (1996-1999) NO LONGER AVAILABLE Now superseded by ESCOP MONOGRAPHS, 2nd edition (2003)
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