OBJECTIVES Post-marketing surveillance for adverse effects has become an essential element of new drug and medical devices development in the European Union and the United States, especially after the withdrawals of drugs such as cerivastatin and rofecoxib due to major safety issues. Post-marketing surveillance studies (PMS) are used to gather additional information about product safety, efficacy or optimal use. Regulatory Post-Marketing Studies (RPMS) are those requested by regulatory agencies and that the sponsor agrees to conduct to provide additional information concerning the approved product. A database gathering the details of proposed and ongoing RPMS would provide the different stakeholders with a better understanding of previous post-marketing requirements for drugs and medical devices. In addition this information would enable product manufacturers to anticipate regulatory requests. Such a database is currently being developed in the manner described below. METHODS Information about RPMS requested since 2000 is being gathered from different regulatory agency sources including, the Haute Autorité de Santé – HAS (France), the European Medicines Agency - EMEA (EU) and the Food and Drug Administration – FDA (USA). The following categories will be displayed for each product in the database: product description, application details, pharmacological action, information source and RPMS details, with a link to the source documents. The search facilities will include these fields among many others. The database will be available online in an independent website, with access by subscription. RESULTS Preliminary results will be presented describing the development and current content of the database. CONCLUSIONS This project will be a unique source of centralized information about RPMS requested in Europe and in the US. It will be useful to observe the current trends in studies requested, to anticipate the demands, and to integrate the studies as early as possible in the product development process.