TGA’s new report on cell and gene therapy regulation


The Therapeutic Goods Administration (TGA) has recently responded to stakeholder feedback on improving cell and gene regulation in Australia by releasing the ‘Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives’ report.

The report includes TGA’s responses to recommendations proposed by engagement with Australian stakeholders that wherever possible TGA will continue to align definitions and classifications with international regulators, will instigate a review of the Clinical Trial Approval (CTA) process, including the need for an education campaign to raise awareness and clarity of the timeframes and process, and increase guidance on Good Manufacturing Practice (GMP) requirements at various stages of cell and tissue therapy development.

Additionally, the report notes feedback that TGA and the Office of the Gene Technology Regulator (OGTR) have instigated a process to review their interactions around Genetically Modified Organisms (GMOs), including a revision of guidance material published on TGA’s website and the TGA has been working with Pharmaceutical Benefits Advisory Committee (PBAC) and Medical Services Advisory Committee (MSAC) that will increase collaboration and enable parallel processing and TGA Registration Pathways.

In response to feedback on TGA registration pathways, the TGA completed a consultation on the potential introduction of a Priority Pathway for biologicals, and a proposal is now before government. AusBiotech responded to that consultation in March 2022, citing that AusBiotech Members regularly utilise these expedited pathways internationally and the opportunity to introduce a priority pathway for biologics into Australia was warmly welcomed. TGA continues to offer a regulatory pathway that will enable patients with unmet clinical needs more timely access to innovative, novel technologies.

TGA commissioned MTPConnect in November 2021 to conduct a stakeholder engagement review, and it will now progress separate consultations on the items arising out of the recommendations, with implementation of any changes requiring approval by the Federal Government.

To download the report and read the recommendations, click here.