- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Regulatory Support
(1998; 49 pages) [French] [Spanish]
Attempts to Meet the Need for Harmonization
To achieve free movement of medicines within the common market of the European Union, and a centralized system of marketing authorization (e.g., for new chemical entities) with the possibility of application at national level only, a system of mutual recognition of marketing authorization decisions has been installed . This "decentralized procedure" provides, as a general rule, that an assessment by one national authority should be sufficient for subsequent registration in other Member States. Under this procedure, the so-called "Summary of product characteristics (SPC)" approved by the first authority must be taken into account. If differences in evaluation occur between national authorities, a decision will be reached by an EC procedure. In accordance with the new EC Directive, this decision is binding from the beginning of 1995, and may - in case of a negative result - have a negative rebound effect on the first registration in an EC Member State, this registration being annulled if the applicant does not withdraw the application for recognition of the dossier. As uniform criteria at a European level regarding the assessment of safety and efficacy do not exist, there is only a guideline for quality of herbal remedies . The harmonization of scientific assessment is considered a precondition for adjustment of different marketing authorization decisions, particularly in the field of phytomedicines in which there are different national viewpoints and traditions.
The European Scientific Cooperative on Phytotherapy (ESCOP) was founded in 1989, the main objectives being to establish harmonized criteria for the assessment of phytomedicines, to support scientific research and to contribute to the acceptance of phytotherapy at a European level . In October 1990, the first five monographs were presented at a symposium in Brussels and were officially handed over to representatives of the European Community. After a thorough assessment, the Committee on Proprietary Medicinal Products (CPMP) published four monographs on anthraquinone laxatives in May 1994 , but no decision was made in case of Matricariae flos and Valerianae radix. Although this was disappointing for ESCOP, it was decided to continue preparing harmonized SPC proposals so as to fulfil an obligation to the European Union for 50 monographs by end of December 1996. Criteria for the selection of medicinal plants and the preparation of draft SPCs by the Scientific Committee are mainly their importance in European countries and their inclusion in the European Pharmacopoeia or a national pharmacopoeia. The draft is then discussed thoroughly by the Scientific Committee, sometimes with external experts from universities or companies. When a harmonized draft is regarded as finalized by the Scientific Committee, it is circulated to an independent Board of Supervising Editors. Members of this Board are scientists and teachers from European universities, mainly active in the field of pharmacognosy and pharmacology .
To be in line with the CPMP requirements laid down in European guidelines, the drafts which are planned to be submitted to the CPMP have the format of a Summary of Product Characteristics (SPC). An SPC describing a medicinal plant and its preparations refers to a Pharmacopoeia monograph with respect to quality, and lists the main constituents that may possibly contribute to the effect claimed. The most important parts of an SPC are the therapeutic indications, the dosage and the pharmacological properties. The latter paragraph gives as many details as possible on pharmacodynamic properties, pharmacokinetic properties and preclinical safety data, each statement supported by references. The SPC text is followed by a list of references, sometimes more than 80, describing in detail all the papers that have been used for the evaluation of safety and efficacy of the respective medicinal plant and its preparations .
ESCOP hopes that the CPMP will perform an assessment of further drafts in the near future, but the members are not too optimistic because at a European level different priorities in the evaluation of medicines have to be set. Nevertheless, ESCOP is of the opinion that all the drafts that have been prepared in the past years might be of great interest as scientific papers, and for this reason 20 monographs were published in March 1996, and further publications are planned .