OBJECTIVES: Anwendungsbeobachtungen (AWBs) are a common type of postmarketing surveillance studies in Germany. They provide information about medical benefit, safety, and effectiveness of drugs in daily practice and can support reimbursement decisions. As practice based research gains in importance the scientific quality of AWBs was evaluated. METHODS: The German drug law demands the reporting of AWBs to NASHIP. In the examined six-month period (July to December 2005), 453 AWBs were announced to NASHIP. Onehundredeighteen were announced for the first time, the others were supplementary information to ongoing AWBs. AWB-conducting companies were asked for more detailed information and AWBs designs were analysed by a validated data entry form that was based on recommendations of the Federal Institute for Drugs and Medical Devices for the conduct of AWBs. RESULTS: One hundred-eight AWBs included statements about goals: 46% listed drug utilisation, 87% safety, 68% effectiveness and 24% QoL. Only a third of AWBs chose a suitable design, basically those that examined safety and drug-utilisation. Only 10% were comparative. Most evaluated drugs were high-priced up to costs of Euro 4500 per prescription. Almost 50% of all drugs had obtained marketing authorisation during the last five years. Median observation time per patient was 140 days. Only 19% of all AWBs mentioned a planned publication of results explicitly. CONCLUSIONS: This study showed the very heterogeneous quality of AWBs in Germany. In most AWBs the marketing aspect dominated obviously and they were not suitable for reimbursement decisions on the basis of the price-benefit ratio.