The TGA has responded to the issues raised in the 2021 Report on Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives
Background
First introduced in May 2011, the regulatory framework for biologicals provides the legislative basis for the regulation of human tissue and cell-derived products as well as live animal cell, tissues or organs that are supplied, in or exported from, Australia. For those therapeutic goods, regulated by the TGA and produced by genetic manipulation (GM), the TGA is required to seek advice from Office of the Gene Technology Regulator (OGTR) (TGA, 2004).
Indications from international regulators on submissions, as well as the sheer number of trials currently being undertaken in this space, suggest that Australia will see significant increases in the number of applications for these types of therapies over the next decade.
The House of Representatives Inquiry (The inquiry)
The Inquiry into approval processes for new drugs and novel medical technologies in Australia” (“the Inquiry”) received multiple submissions that voiced concerns with aspects of the current regulatory framework, in particular concerning gene therapies. These included concerns regarding the following:
- the communication of the different processes,
- parallel regulation and reimbursement processes,
- the TGA-OGTR interface and clinical trial pathways,
- priority and provisional access pathways.
Following on from these submissions and acknowledging the rapidly changing landscape of therapeutics, the TGA sought stakeholder input on:
- whether there is opportunity for improving TGA communication of the regulatory framework, in particular, for biologicals; or
- whether there is the modifications to some aspects of the regulatory framework, such as review of mechanisms of TGA-OGTR interface, and priority, provisional and parallel application pathways.
The consultation
In November 2021 the TGA asked MTPConnect to conduct a stakeholder consultation to review Australia’s regulatory framework for gene, cell and tissue therapies. The review involved individual interviews and group sessions with key stakeholders from across the sector, including from:
• Pharmaceutical and biotechnology industry
• Clinical trials
• Regulatory
• Clinicians
• Researchers
• Ethics committee
• Manufacturing
• Patient advocacy/consumer groups.
The report
Following the consultation, a report entitled Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives was published.
Core themes were distilled from the consultation notes associated with the questions. Key themes to emerge from the consultations to ensure Australia is competitive and patients have access to these new medicines with fit for purpose and harmonised processes include:
- TGA’s flexibility and willingness to engage with stakeholders and seek feedback was commended, but it was suggested that the TGA could be more proactive in communication of how cell and tissue therapies are regulated.
- Better communication by the TGA. This included the need to simplify the language and provide contemporary information on the website, supporting better understanding of the clinical trial and regulatory pathways as well as interactions/interdependencies with other regulators.
- Alignment with Comparable Overseas Regulators is recommended with respect to biologicals definitions and classifications, dossiers, pathways, and data requirements. Industry stakeholders noted there had been significant improvements with evaluating dossiers which had previously been submitted to Comparable Overseas Regulators.
- Stakeholders involved in clinical trials stated that the Clinical Trial Approval (CTA) process needed improvement and TGA’s CTA review timelines needed to be equivalent to international benchmarks.
- It was noted that the biologicals pathway was less well-defined relative to the prescription medicines pathway. Some stakeholders asked that these therapies have access to orphan drug pathways as well as expedited (priority) pathways based on patient needs.
- Reduced duplication of effort in submission of information by product developers to different Australian regulators. Industry stakeholders and patient advocacy group representatives proposed that there should be a single point of entry for data requirements and a more streamlined approach to enabling patient access to new therapies.
The TGA response to the consultation report
The TGA has now responded to the consultation report under the following six key topics:
- Terms and Definitions
- Clinical Trial Pathways
- Good Manufacturing Practice (GMP)
- TGA-OGTR interactions
- TGA Registration Pathways
- Pharmaceutical Benefits Advisory Committee (PBAC)/Medical Services Advisory Committee (MSAC) interface with TGA
The tabulated response is a available here.
Source: TGA