Regulatory Situation of Herbal Medicines A worldwide Review

WHO/TRM/98.1page 11In accordance with the "Regulations for Registration of Herbal Preparations, Health and Supplementary Food,Cosmetics and Antiseptics that have Medicinal Claims" issued by the Ministry of Health of the Kingdom ofSaudi Arabia, the formal application for registration which is submitted to the General Directorate of Medicinaland Pharmaceutical Licences at the Ministry of Health is based on the registration of the product in the countryof origin. For this reason, documents such as manufacturing licences, free sales certificates, and GMPcertificates have to be submitted with information on composition, therapeutic category, certificate of analysis,percentage of alcohol and, in the case of ingredients of animal origin, the kind of animal. Furthermore, fullspecifications and methods of analysis of the finished product, data on stability studies and storageconditions, six samples of the product and of the outer package and label, together with abstracts of scientificreferences testifying to the efficacy and safety of the product have to be submitted [47]. Handling of locallyproduced or imported products is prohibited before registration by the Ministry of Health. After registration it isnot allowed to make any change in the composition, specification, method of manufacturing, indications,container or package unless it has been approved by the authority. A registration may be cancelled by theauthorities under certain pre-conditions. The registration committee reviews registered products after threeyears from the date of registration, or as deemed necessary, to consider the need for re-registration [29].EuropeGeneral aspectsThe European Community has developed a comprehensive legislative network to facilitate the free movementof goods, capital, services and persons in the Community. According to Directives 65/65/EEC [30] and75/318/EEC [31], pharmaceutical products require pre-marketing approval before gaining access to themarket. Requirements for the documentation of quality, safety, and efficacy, the dossier and expert reports arelaid down in Directive 91/507/EEC [32]. Article 39 para 2 of Directive 75/319/EEC [33] obliged Member States tocheck all products on the market at that time, with a deadline of 12 years, to determine whether they met therequirements of these directives. Countries have taken different approaches in reviewing phytomedicines.Attempts to Meet the Need for HarmonizationTo achieve free movement of medicines within the common market of the European Union, and a centralizedsystem of marketing authorization (e.g., for new chemical entities) with the possibility of application at nationallevel only, a system of mutual recognition of marketing authorization decisions has been installed [34]. This"decentralized procedure" provides, as a general rule, that an assessment by one national authority should besufficient for subsequent registration in other Member States. Under this procedure, the so-called "Summary ofproduct characteristics (SPC)" approved by the first authority must be taken into account. If differences inevaluation occur between national authorities, a decision will be reached by an EC procedure. In accordancewith the new EC Directive, this decision is binding from the beginning of 1995, and may - in case of a negativeresult - have a negative rebound effect on the first registration in an EC Member State, this registration beingannulled if the applicant does not withdraw the application for recognition of the dossier. As uniform criteria ata European level regarding the assessment of safety and efficacy do not exist, there is only a guideline forquality of herbal remedies [35]. The harmonization of scientific assessment is considered a precondition foradjustment of different marketing authorization decisions, particularly in the field of phytomedicines in whichthere are different national viewpoints and traditions.The European Scientific Cooperative on Phytotherapy (ESCOP) was founded in 1989, the main objectivesbeing to establish harmonized criteria for the assessment of phytomedicines, to support scientific researchand to contribute to the acceptance of phytotherapy at a European level [36]. In October 1990, the first fivemonographs were presented at a symposium in Brussels and were officially handed over to representatives ofthe European Community. After a thorough assessment, the Committee on Proprietary Medicinal Products(CPMP) published four monographs on anthraquinone laxatives in May 1994 [37], but no decision was madein case of Matricariae flos and Valerianae radix. Although this was disappointing for ESCOP, it was decided tocontinue preparing harmonized SPC proposals so as to fulfil an obligation to the European Union for 50monographs by end of December 1996. Criteria for the selection of medicinal plants and the preparation ofdraft SPCs by the Scientific Committee are mainly their importance in European countries and their inclusionin the European Pharmacopoeia or a national pharmacopoeia. The draft is then discussed thoroughly by theScientific Committee, sometimes with external experts from universities or companies. When a harmonizeddraft is regarded as finalized by the Scientific Committee, it is circulated to an independent Board ofSupervising Editors. Members of this Board are scientists and teachers from European universities, mainlyactive in the field of pharmacognosy and pharmacology [38].