Presentation: Reforming Australia’s therapeutic goods testing regulations

The Laboratories Branch will provide a high-level overview of our ongoing public consultation, in relation to proposed changes to the Therapeutic Goods Regulations 1990 (the Regulations). Specifically, we are seeking feedback on proposed changes in relation to Part 5 of the Regulations (Part 5), which sets out the procedures for the examination, testing and analysis of therapeutic goods. 

Learn how we propose to strengthen and modernise Part 5 to ensure that the Regulations are contemporary and flexible, while also reinforcing high standards of quality, safety and performance of therapeutic goods in Australia. The event will have time for a question-and-answer session at the end. 

We strongly encourage participants to read the paper prior to the session, to maximise the benefit of this time. 

Background

In line with the Health Regulatory Policy Framework, we conducted a review of Part 5 of the Regulations to determine the suitability for conducting sampling and testing activities. The review showed that there are gaps in our current legislative framework that need to be addressed. We have identified a number of reform opportunities to strengthen and enhance this component of the testing framework. 

The proposals outlined in the consultation paper are intended to provide all stakeholders with increased transparency and confidence in the TGA Laboratory testing program, while allowing greater flexibility and responsiveness of the testing framework. 

Speaker

• Emma Deaves, Strategic Reforms Officer, TGA

Slides