ABSTRACT
Much progress has been made towards standardising the requirements for and the format of marketing applications. Probably the greatest changes have occurred in the European Community through the drive of the European Commission to achieve a unified procedure by 1992. When regulatory authorities are involved in reviewing the data which are submitted to support a proposed clinical trial, in the majority of cases they operate a negative vetting procedure. In the majority of other countries the regulatory authorities review the safety and quality data presented to them in summary form and, if appropriate indicate, that they have ‘no objections’ to the proposed trial. Some regulatory authorities require full safety reports to be included in applications to undertake clinical trials. Ethics committee approval is required before undertaking clinical trials in all countries. Most regulatory authorities will be satisfied if the standard ‘European’ requirements are followed for the duration of the acute/subacute animal safety studies.
