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 program 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 1,800 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.