Some Insights into the TGA’s Risk Management Approach
As the regulator of prescription medicines, part of the role of the TGA is to facilitate the supply of medicines of an acceptable quality, safety and effi cacy to the Australian public. To do so, the TGA employs a risk management approach. Two recent changes which stem from the TGA’s Business Process Reforms illustrate the TGA’s evolving approach to the regulation of prescription medicines in Australia. This article provides a brief overview of two new measures that affect how the TGA goes about discharging its regulatory functions. Even at this early stage of implementation, it is possible to see a push towards the increased monitoring of the safety of prescription medicines, especially at a post marketing stage. Another emerging challenge is how to best strike a balance between transparency and the protection of commercial know how.
To access the full article, please login to the Members Area or if you are not yet an ARCS Member join now.