In Germany, issues surrounding quality control and standardization of herbal products are less of a concern than elsewhere because ethical botanical manufacturers use the same high-quality production standards found in the synthetic drug industry. However in terms of legal status, herbal medicines are fully considered as medicines according to the Second Medicines Act of 1978 which determines the standards for the granting of marketing authorization in accordance with the European framework for the handling of medicines. Under this new regulation, proof of quality, safety and efficacy became an essential precondition for the registration of medicines. All products on market at the time of issuance of the directive were allowed to continue being marketed with a so-called fiction marketing authorization for a 12-year transition period until 31 December 1989. To meet the requirements of the new Medicines Act, the authorities were obliged to carry out a review of active principals, which resulted in monographs and product-specific verification of pharmaceutical quality and conformity with published monographs. The review largely focused on active ingredients and established an a priori criterion for the same. The review of herbal remedies was done by a pluridisciplinary commission of experts – the Commission E – with pharmacists, pharmacologists, toxicologists, clinical pharmacologists, biostatisticians, medical doctors from hospitals and general medical practitioners. Established in 1978, Commission E is an independent division of the German Federal Health Agency that collects information on herbal medicines and evaluates them for safety and efficacy.

This commission responsible for the evaluation of more than 300 medicinal plants received pharmaceutical, pharmacological and clinical data along with data from international side-effect monitoring system and publications from the Health Authority. The work also supported by the ‘Kooperation Phytopharmaka’ resulted in the compilation of a prepublished draft monograph that was open for remarks from companies and other interested parties. Later the monographs covering most of the ingredients of industrially prepared herbal medicines were published officially in the Federal Gazette, Bundesanzeiger, and this scientific evaluation formed the basis for marketing authorizations and review decisions of the Federal Institute for Drugs and Medical Devices, Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM), responsible for the assessment of medicines and the verification of submitted dossiers with respect to quality, safety and efficacy. The monographs include analytical test requirements and also texts for labels and package leaflets with 279 monographs of standardized marketing authorizations for herbal teas. While ‘positive monographs’ pertain to those that cover all relevant indications including package leaflet or consumer information such as drug composition, form of applications, indications, contraindications, warnings, dosage etc. a substantial number of ‘negative monographs’ is for those that involved risks from active ingredients or had no reasonable proof of efficacy. The work of all review commissions including the Commission E regarding the evaluation of bibliographic data and preparation of monographs was finalized in the Fifth Amendment of the Medicines Act. The commissions are now advisory boards to the health authorities in making decisions on the registration of new drugs, and in the individual assessment of old medicinal products already on the market.