Table 5 Therapeutic Goods Administration – Risk-based post-marketing quality surveillance as a critical regulatory function

Australia’s NRA, the Therapeutic Goods Administration (TGA), has been 100% cost recovered (autonomous, but self-funded) since the late 1990s. Cost-recovery compels the organization to think strategically about the implementation of its regulatory functions. In 2011, TGA assessed its testing program, identified areas of improvement, and set a roadmap for investing in and establishing a risk-based PMQS program for its programmed testing activities. Risk management standards were consulted and adapted to TGA’s context, principles were identified (e.g., the program would need to be dynamic, iterative, and responsive to change), and a framework and related foundational processes were developed (e.g., risk analysis, risk management, impact evaluation, risk communication).

The program took 3 years to develop, primarily because of the complexity of designing a system that would cater to and enable risk scoring of all product categories (e.g. over-the-counter medicines, complementary medicines, and medical devices). The program has now been active for several years and, importantly, publishes testing data through TGA’s website. Products that undergo a more intensive pre-market assessment (e.g. prescription medicines), tend to score lower and are therefore tested less frequently. However, groups within categories can be scored differently. For example, both vaccines and biological medicines are regulated as prescription medicines in Australia but score more highly than other prescription medicines in general. This is due to the increased complexity of the products and increased complexity of manufacturing; in the case of vaccines, it is also because they are given to an entire cohort of healthy children every year. The risk category of a product can also be elevated (a dynamic program) in response to specific factors, such as poor GMP, failed laboratory testing results, or adverse event reports.

Key to the success of the program was political will and staff commitment, which enabled the development and implementation processes to be followed thoughtfully and have led to less resource waste, increased effectiveness (e.g., shifting the type of products that are tested), and identification of poor-quality products.