TGA Strategic Management Environment Project update

The Strategic Information Management Environment (SIME) project is a TGA initiative to enhance the collection, management and reporting of TGA business information. The project is starting to gather momentum, with many of our systems nearing their release date. The Listed Medicines Assessment Engine has been completed and Listed Medicines staff are using it as the first step in the assessment of listed medicine applications submitted through the Electronic Lodgement Facility (ELF). The engine has removed the need for many of the tedious manual calculations associated with the assessment of listed medicine applications. This has enabled the unit to concentrate on developing business rules for the new online ELF for Listed Medicines.

The Devices Electronic Application Lodgement (DEAL) system has completed an Industry Pilot. A group of industry volunteers trialed the system and provided feedback to the TGA. The feedback is being incorporated into the final DEAL system.

We will continue to keep you updated on progress of the SIME project, and how you can be involved, in future issues of TGA News.