Reforming Australia's Therapeutic Goods Testing Regulations

Our review of Part 5 showed that there are gaps in our current legislative and regulatory framework for sampling and testing. We have identified a number of reform opportunities to strengthen and enhance this component of the testing framework. The problems and associated proposals outlined in this paper (attached below) 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.

Your views are sought on the following four key problems and our proposals for reform:

Problem 1. Limited application of the testing framework.

The testing framework is no longer fit for purpose as it does not adequately align with the expanded scope of the therapeutic industry, or provide coverage for emerging innovations.

We are seeking to broaden the application of the testing framework to increase the scope of samples that can be tested under the framework, as well as where and how samples can be obtained, or received for testing.

Problem 2. Prescriptive processes that are inflexible, unclear and burdensome.

Part 5 has many regulations that are overly prescriptive and no longer align with modern best laboratory and regulatory practice. This will hinder future progression and innovation. There is also a lack of clarity stemming from unclear processes with gaps or duplicative information. This creates difficulties and inconsistencies for interpretation, compliance and administration.

We are seeking to clarify and streamline processes and definitions.

Problem 3. Complex and inefficient procedures regarding the evidentiary certificate.

There are multiple complex procedures in Part 5 for the production and use of the evidentiary certificate. These procedures are convoluted and often duplicative of other areas of the legislative framework. There are multiple processes and procedures that can be improved to decrease ambiguity and increase fairness and transparency.

We are seeking to amend procedures for the requirements, release of information and reliance on evidentiary certificates.

Problem 4. Insufficient protection for staff while performing their duties.

The regulations in place to protect staff while performing their duties have a narrow scope of application which has exposed staff to inappropriate behaviour.

We are seeking to expand the provision for offences relating to intimidation of staff members in the conduct of their duties.