The Therapeutic Goods Administration (TGA) is seeking public comment on proposed reforms to Part 5 of the Therapeutic Goods Regulations 1990. The proposed reforms are aimed at strengthening and modernising the legislative framework for the examination, testing and analysis of therapeutic goods.

The TGA Laboratories are responsible for delivering results on the quality and performance of therapeutic goods. The testing conducted by the TGA 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.

The proposed reforms will impact the procedures for examination, testing and analysis of goods that we conduct within the regulatory framework.

The TGA is seeking consideration of proposed reforms to Part 5 to ensure this improvement activity strikes the right balance of safety for consumers and patients without imposing unnecessary regulatory burden on industry. The TGA understands that changes to legislation can impact how businesses make decisions. Your engagement is critical to ensuring that these reforms are fit for purpose.

The complete consultation, including your opportunity to provide feedback, can be found at https://consultations.tga.gov.au/medical-devices-and-product-quality-division/reforming-australias-therapeutic-goods-testing-reg

The consultation closes on 18 August 2024.

This news item was issued on 16 July 2024 by Jill Smith, CEO of ASCIA, the peak professional body for clinical immunology and allergy in Australia and New Zealand.