Reforming Australia's Therapeutic Goods Testing Regulations

Overview

The Therapeutic Goods Administration (TGA) is responsible for protecting the health and safety of the community by regulating therapeutic goods for safety, efficacy, performance, and quality. We do this through the application of the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods Regulations 1990 (the Regulations) and associated legislation.

The TGA Laboratories are responsible for delivering results on the quality and performance of therapeutic goods. The testing we conduct assesses compliance with quality and performance standards for the therapeutic goods. This testing provides the TGA, as the regulator, with scientific data to inform and support regulatory decisions and actions, ensuring the safety of therapeutic goods for Australian consumers.

Part 5 of the Regulations (Part 5) sets out procedures for examination, testing and analysis of goods to be conducted within the regulatory framework. Currently, this Part is applicable to only a subset of our sampling and testing activities.

In line with the Health Regulatory Policy Framework (HRPF), we have conducted a review of the Regulations to determine the suitability of Part 5. Our review looked to ensure Part 5 was a regulatory system that:

• is fit for purpose (i.e., is well designed for its intended outcomes)
• takes into account the latest innovations,
• is efficient to comply with and administer,
• is effective in achieving its outcomes, and
• is fair, transparent, and resilient.

Our review has concluded that Part 5 does not currently meet these criteria. We are seeking your input on proposals that aim to align Part 5 with the HRPF and enhance the Regulations to protect the health and safety of Australians, while minimising unnecessary compliance burden.

Background

The role of therapeutic goods testing

Therapeutic goods can comprise a broad range of things, but are generally categorised as medicines, biologicals, or medical devices. We also regulate other therapeutic goods which do not meet the definitions of medicines, medical devices, or biologicals, such as tampons and disinfectants. Regulatory testing of therapeutic goods is an important part of safeguarding the health and well-being of the Australian public. Our laboratory testing activities provide a critically important level of support to post-market monitoring, including compliance and enforcement action, in relation to breaches of the Act and its regulations.

Our testing focuses on the quality of therapeutic goods that are used in, or exported from, Australia. For medical devices, testing can also include a device’s ability to meet intended performance specifications. This testing provides the TGA, as the regulator, with scientifically robust data to support regulatory decisions and, as necessary, compliance and enforcement action.

Our Laboratories contribute to the TGA’s reputation as a world-class regulator by enabling continuous improvement and building trust, supporting risk-based and data-driven regulatory practices, and promoting collaboration and engagement.

Part 5 of the Regulations

Part 5 sets out procedures for examination, testing and analysis of goods to be conducted when testing within the regulatory framework. Currently, this Part is applicable to only a subset of our sampling and testing activities. These Regulations are principally designed to ensure the integrity of test results of samples tested by the TGA for the purpose of identifying whether the goods are safe for use, and comply with important elements of the regulatory scheme, such as applicable standards.

A key component of this testing framework is the production and issuing of a regulation 29 certificate of responsible analyst at the conclusion of testing. This certificate includes the results of the testing performed, as well as a statement about whether the goods complied with a relevant requirement for safety, efficacy, performance or quality standards. This certificate can be used in proceedings under the Act or the Regulations as evidence.

Why your views matter

We are committed to continuous improvement and consulting with stakeholders on proposed changes to policy and legislation.

This consultation paper outlines a number of legislative reforms we are proposing, to strengthen and modernise the legislative framework for the examination, testing, and analysis of therapeutic goods. These proposed changes aim to improve the clarity and functionality of the arrangements in Part 5.

Our goal is to ensure that the Regulations are contemporary and flexible, allowing for future development, while also reinforcing high standards of quality, safety, and performance of therapeutic goods in Australia.

We are seeking your consideration of proposed reforms to ensure this improvement activity strikes the right balance of safety for consumers/patients without imposing unnecessary regulatory burden on industry. We understand that changes to legislation can impact how businesses make decisions. Your engagement is critical to ensuring that these reforms are fit for purpose.

What happens next

Feedback from written submissions will be used by the Department to refine the legislative proposals described in this consultation paper. Your feedback will help us build a full picture of the impacts of these proposals. Any regulatory burden will be carefully considered alongside the benefit from the proposed changes.

After reviewing your feedback on the proposals in this consultation paper, the Department will provide advice to the Government on updates to the legislation to implement the proposals.

Responses to this consultation will be collated and published on the website as below.