- Prof. Dr. Anna Rita Bilia – Italy
- Prof. Dr. Pavel Chirilă – Romania
- Dr. Jozef G. Corthout – Belgium
- Dr. Maria do Céu Costa – Portugal
- Dr. Dezsö Csupor – Hungary
- Prof. Dr. med Jürgen Drewe – Switzerland
- Dr. F. M. Van den Dungen – Netherlands
- Dr. Sarah Edwards – United Kingdom
- Dr. Marijke Frater-Schröder – Switzerland
- Dr. Lene Gudiksen – Denmark
- Dr. Didier Guédon – France
- Dr. Ingrid Hook – Ireland
- Dr. Stephan Horsten – (Co-Chairman) – Netherlands
- Roberta Hutchins – United Kingdom
- Assoc. Prof. Dr. Liselotte Krenn – Austria
- Dr. Frédérique Lafforgue – France
- Dr. Radu Moldavan – Romania
- Dr. Andrzej Ostrowicz – Poland
- Dr. Georg Seidel – Germany
- Dr. Barbara Steinhoff – (Co-Chairman) – Germany
- Dr. Sonja Sturm – (Co-Secretary) – Austria
- Prof. Dr. Funda Nuray Yalçin – (Co-Secretary) – Turkey
The Scientific Committee of ESCOP has since the foundation of ESCOP led the work 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.