Good therapy for the Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA) carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard. The TGA ensures that the Australian community has access, within a reasonable time, to therapeutic advances. The regulatory framework is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden.
Apis was asked by TGA to assist in a program of business reform in the regulation of medical devices. The reforms targeted improved timeliness to market of new medical devices, in a way that did not compromise TGA’s high standards of regulation for safety and efficacy.
It was around this core tenet of timeliness to market that Apis was engaged. The length of time the TGA required to audit a new product application had moved out beyond acceptable targets, delaying the release of those products that were deemed safe and beneficial.
Using Apis’ Business Process Design methodology, the TGA audit system was put under the microscope. Process mapping was undertaken across the full Medical Devices lifecycle to market (Tier 1). Within each phase of the lifecycle to market, Apis undertook detail process analysis and design (Tier 2). This work was used to streamline key activities, remove bottlenecks and identify gates for tracking operational activity.
Apis’ analysis included detailed modelling of evaluation activity, matching work effort to each process step. This allowed better organisation of limited TGA resources, with significantly improved ability to track and monitor all applications at different points in the lifecycle. Apis’ analysis was pivotal to modelling and managing a large backlog of applications that had stockpiled from recent changes to regulation. Apis’ modelling was proven to be highly accurate when compared to actual backlog clearance rates.
With processes in place, the TGA successfully cleared its backlog of audit applications and went on to apply this new thinking to its everyday influx of applications. In addition to delivering a significant boost to team moral, application audit deadlines are now met consistently, enabling quality new therapeutic products to enter the market swiftly.