Cell, tissue and gene therapies – Regulatory challenges and responses in Australia

Australian regulation of cell, tissue, and gene therapies (CTGT) is relatively new, with the regulatory framework for biological medical products first being introduced in 2011. A decade onwards, the Therapeutic Goods Administration (TGA) commissioned a stakeholder review to assess current issues and roadblocks for participants in the CTGT space. We have summarized below the major themes of the report, which include legislative changes to accommodate biological products and streamlined pathways for clinical trials and patient access.  


In November 2021, the TGA commissioned a stakeholder review of the regulatory framework. The report ‘Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives’ was published in July 2022 along with the TGA’s proposed responses to the issues raised in the report.

Key issues

Several pain points were identified by stakeholders in the report, including (among others) the following:

  1. 1. Increased certainty and clarity in the clinical trials process

The clinical trial process for CTGT products is uncertain, lengthy and resource intensive, and needs to be improved to meet equivalent international benchmarks. Additionally, many novel CTGT developments are classified as ‘Class 4 biologicals’ and are determined to be high risk. This limits these products to being assessed under the Clinical Trial Approval (CTA) scheme, which is more expensive, complicated and time-consuming in comparison to the Clinical Trial Notification (CTN) scheme.

  1. ​​​​​​​2. Need for clear patient access pathways

Pathways for access to CTGT or other biological drugs is not well-defined. There is a need for clearer and more streamlined pathways. This includes priority review pathways and pathways for obtaining orphan drug status (which currently is not available for biologicals in Australia).

  1. 3. ​​​​​​​Communication between regulators & parallel processing

There is a need for interactions between other relevant regulators to be more collaborative and streamlined.  These include, for example, the Office of the Gene Technology Regulator (OGTR) and health technology assessment bodies such as the Pharmaceutical Benefits Advisory Committee who handle reimbursement.

Stakeholders also conveyed that a single point of entry for submitting information would be preferred to avoid duplication of work.

TGA response

Actions taken by the TGA include:

  • the introduction of a priority review pathway for biologicals.  Previously, there had been no formal mechanism to expedite the assessment and inclusion of biologicals in the Australian Register of Therapeutic Goods (ARTG). Consultation of the priority review pathway for biologicals was completed earlier this year, and the pathway was introduced on 1 October 2022. Under the new Part 3D of the Therapeutic Goods Regulations 1990 (Cth), novel biologicals which are intended for the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition may be eligible to apply for expedited assessment and inclusion on the ARTG;

  • completion of a consultation on a pathway to approve ‘export only’ biologicals.  It is proposed to allow suppliers of biologicals (such as CTGT products) to export biological products overseas with different indications to their Australian counterparts, assisting with the commercialisation of such products. Amendments to the Therapeutic Goods Act 1989 (Cth) and Therapeutic Goods Regulations 1990 (Cth) to allow for the ‘export-only’ pathway are expected to be completed by the end of 2022;

  • initiating a review of the CTA pathway, including the need for educational campaigns regarding timeframes and processes; 

  • commencing discussions with the OGTR to review interactions around genetically modified organisms and to revise guidance material published by both regulators; and

  • engaging a Digital Transformation Project, which will include support for the National One Stop Shop (a national online platform that will combine all agencies involved in clinical trials in one place to minimise duplication of work). 

Next steps

While the TGA has not announced major changes to the regulations, it is clear that regulatory changes in the form of new approval pathways are on the horizon. Companies intending to conduct clinical trials in Australia or expand their business to Australia should keep abreast of any changes.

Please reach out to us if you have any questions.


Authored by Mandi Jacobson and Angell Zhang


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