The purpose of this guide is to provide advice on introducing any computer-assisted drug registration system. This entails undertaking preparatory work to meet prerequisites, organizing working procedures, establishing information formats, securing resources, and training staff on the new system. This is not a guide on drug registration and contains only minimum guidance on that process, in order to provide an appropriate context for the discussion. A brief description of the drug registration process can be found in Annex 2.
The target audience of this manual is officials of national drug regulatory authorities at the decision making and operational levels. Decision makers need to understand the implications of introducing a new system, in terms of organization of work, distribution of tasks, and automation of certain correspondence and certification procedures. Operational staff need to understand how their work may be changed by the new system. In particular, it will require a more systematic approach to handling information, but in return the system will provide a greater degree of freedom of access to information and reduction of repetitive tasks.