24 December 2015
In 2014, the APVMA engaged the Centre of Excellence for Biosecurity Risk Analysis to develop an application profiling tool that could identify applications suited to a lower level of regulatory intervention.
The APVMA screening level risk assessment tool—final report outlines the principles and criteria for an application profiling tool or decision tree that aggregates information on a range of factors relevant to applications for approval, registration and variation.
The decision tree replicates the logic deployed by the APVMA in its preliminary decision-making to determine whether an application can be approved without detailed assessment.
The report has informed our business improvement work including the development of a fast-track registration process, an expanded list of notifiable variations and additional product standards.