TGA Reform Priorities for 2027: Accelerating Access to Medicines for Australians
Australia's Therapeutic Goods Administration (TGA) is the Commonwealth's medicines and devices regulator, operating within the Department of Health and Aged Care and funded primarily through industry cost-recovery fees. The TGA's mandate is broad: it evaluates and registers prescription medicines, biologics, medical devices, blood products, over-the-counter therapeutics, and complementary medicines; it administers the Australian Register of Therapeutic Goods (ARTG); and it oversees post-market surveillance and recalls.
The TGA is widely regarded as a technically competent regulator. It is not, however, structured for the pace of therapeutic innovation that characterises the 2020s. Average approval timelines for new medicines lag behind the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in several important categories. The provisional approval pathway — introduced in 2022 to address this — has been underutilised. Biosimilar uptake in Australia remains well below comparable OECD nations. The March 2025 rescheduling of BPC-157 and related peptides to Schedule 4 created a compounding pharmacy regulatory environment whose long-run consequences are still being worked through. Digital therapeutics — software as a medical device, prescription digital therapeutics, AI-driven diagnostic tools — lack a fit-for-purpose regulatory pathway. And the TGA's consultation processes, while formally compliant, are perceived by patient advocacy groups and smaller sponsors as structurally weighted toward established industry actors.
This article examines each of these dimensions and proposes a reform agenda achievable within the 2027 parliamentary term.
Approval Timelines: Where Australia Stands
The Benchmark Problem
The TGA's standard evaluation pathway for new prescription medicines (Category 1 applications, where there is no comparable overseas evaluation) operates on a 255-business-day target from lodgement to decision. A Category 2 application — where the product has been approved by an agreed comparable overseas regulator (the FDA, EMA, Health Canada, UK MHRA, or Medsafe New Zealand) — targets 175 business days. In practice, clock-stop periods (time during which the TGA awaits sponsor responses to requests for information) frequently extend actual elapsed calendar time well beyond these targets.
By comparison, the FDA's standard Prescription Drug User Fee Act (PDUFA) review goal is 10 months from filing acceptance (approximately 295 calendar days, including the application review period). The FDA's priority review pathway targets 6 months. The EMA's centralised procedure for new medicines targets 210 days of active review, with typical total elapsed time (including clock stops and opinion periods) of 12 to 15 months.
On paper, the TGA's 175-day Category 2 pathway is competitive. In practice, the combined effect of clock stops, sequential rather than concurrent evaluation phases, and the TGA's limited use of rolling submission (where data packages are submitted and reviewed as they become available) produces median approval times that typically exceed FDA and EMA timelines for the same products. The University of Sydney's work on comparative pharmaceutical access has documented that Australians wait, on average, 12 to 18 months longer than Americans or Europeans to access newly registered medicines, when measured from first regulatory approval anywhere in the world to TGA registration.
Oncology: The Most Acute Access Gap
The access gap is most clinically significant in oncology. The TGA has approved numerous targeted therapies and immunotherapies years after FDA or EMA approval, during which time Australian patients either accessed unapproved medicines through the Special Access Scheme (SAS) at out-of-pocket cost, enrolled in clinical trials (available to a minority), or went without. Cancer Council Australia's 2024 Access to Cancer Medicines report identified 47 medicines approved by the FDA or EMA between 2018 and 2023 that were not yet registered on the ARTG as of the report date.
The Provisional Approval Pathway: Promise and Underperformance
The TGA introduced a provisional approval pathway in 2022, modelled on the FDA's Accelerated Approval and the EMA's Conditional Marketing Authorisation. The pathway allows registration of medicines that address serious or life-threatening conditions where full clinical data (typically overall survival or definitive endpoint data) are not yet available, conditional on sponsors submitting confirmatory evidence post-registration.
As of mid-2025, the provisional pathway has been used for a small number of products — considerably fewer than the equivalent pathways at the FDA and EMA in comparable periods. Several factors explain the underperformance.
First, the pathway requires sponsors to submit provisional applications separately from standard applications, with a different dossier structure and a distinct evaluation fee. Sponsors who are uncertain whether their product will qualify for the provisional pathway — and the eligibility criteria involve clinical judgment — often default to the standard pathway to avoid the risk of a procedural rejection.
Second, the TGA has not published detailed guidance on what confirmatory evidence obligations look like in practice — specifically, what endpoints, timelines, and submission requirements will govern the transition from provisional to standard registration. Without this clarity, sponsors face post-registration uncertainty that can deter use of the pathway.
Third, the provisional pathway does not interact with PBS listing: a medicine provisionally registered on the ARTG must still complete the standard PBAC evaluation process before PBS listing is possible. The result is that the provisional pathway can accelerate ARTG registration by 12 to 24 months without meaningfully shortening the time to subsidised patient access, since the PBAC clock does not start until ARTG registration is complete. This structural sequencing is a reform priority in its own right.
Biosimilar Uptake: Australia Lags Its Peers
Biosimilars — biological medicines that are highly similar to originator biologics in terms of quality, safety, and efficacy — offer the potential for substantial PBS savings that can be redirected to fund access to novel medicines. Australia's biosimilar uptake has improved since the TGA and Department of Health introduced substitution policies from 2015 onward, but it remains well below comparable jurisdictions.
In the United Kingdom, biosimilar penetration (share of total volume in eligible medicine categories where a biosimilar is available) exceeds 85% in most categories, driven by NHS tendering, formulary management, and active prescriber switching programs. In Denmark and Norway, penetration rates exceed 90%. In Australia, the 2024 PBS data indicate biosimilar penetration rates of approximately 55% to 65% in key categories including etanercept, adalimumab, and infliximab — well below European benchmarks.
The reasons are structural. Australia's PBS does not employ the NHS tender model; instead, it relies on price reductions triggered by biosimilar entry (the "60% price reduction rule") and prescriber incentive mechanisms that have not been consistently effective. Specialist prescribers — particularly rheumatologists and gastroenterologists who manage most of the high-volume biologic categories — have been slow to switch established patients, in part because the clinical risk-benefit communication around biosimilar switching has not been adequately resourced.
The TGA's role in this is indirect but real: clear, consistent, and frequently updated TGA guidance on biosimilar interchangeability — drawing on EMA and FDA interchangeability designations — would reduce the clinical uncertainty that contributes to prescriber reluctance. A more active TGA communication program, analogous to the UK Medicines and Healthcare products Regulatory Agency's biosimilar information campaign, is overdue.
Compounding Pharmacy Regulation: The Post-Rescheduling Environment
The March 2025 rescheduling of BPC-157 and related research peptides to Schedule 4 (prescription-only) under the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) fundamentally changed the compounding pharmacy environment in Australia. For detailed background on the regulatory process that led to this outcome, see our TGA peptide regulation background analysis and the BPC-157 rescheduling case study.
The rescheduling created a more regulated environment for research peptides and regulatory context, but it also created gaps and ambiguities that the TGA and the Department of Health have not yet fully resolved.
Compounding access under Schedule 4. Schedule 4 status means these peptides can be legally compounded by authorised compounding pharmacies and supplied on a valid prescription from an authorised prescriber. In practice, the number of prescribers willing to issue prescriptions for peptides that lack PBS listing and ARTG registration — and who have the clinical familiarity to do so — is small. Compounding pharmacies willing to compound these substances are subject to the Therapeutic Goods (Standard for Compounded Medicines) (TGO 107) requirements, which impose manufacturing quality standards that many smaller pharmacies cannot meet. The practical result is a significant reduction in accessible, quality-assured supply.
Regulatory clarity gaps. The TGA has not issued clear guidance on: (a) the prescribing indications that would constitute appropriate Schedule 4 prescribing for peptides like BPC-157, which lack an approved indication in any major jurisdiction; (b) the documentation and monitoring obligations of prescribers; or (c) the quality and stability testing requirements that compounding pharmacies must meet. This regulatory silence creates compliance uncertainty for both prescribers and pharmacies, and pushes a proportion of demand toward unregulated, non-TGA-assessed supply chains — an outcome the rescheduling was intended to reduce.
The Coalition's position is that Schedule 4 rescheduling, where scientifically justified, should be accompanied by a clear regulatory implementation framework — not left to industry interpretation.
Post-Market Surveillance: Known Gaps
TGA post-market surveillance operates through several mechanisms: the Database of Adverse Event Notifications (DAEN), mandatory adverse event reporting by sponsors and healthcare providers, and post-market reviews triggered by signals in DAEN, overseas regulatory action, or TGA-initiated monitoring programs.
The system has documented structural limitations. Australia's adverse event reporting rates are low by international comparison — a consistent finding in health services research. The DAEN captures a fraction of actual adverse events; the remainder are either not reported to the TGA or reported informally through PBS prescription data or hospital admissions data without linkage to the DAEN. The TGA's 2023 review of post-market surveillance acknowledged that mandatory reporting by healthcare providers is inconsistently applied, that the online reporting interface creates barriers to busy clinicians, and that signal detection from low-volume adverse event data in small populations (Australia's population of 27 million means that rare events may generate too few reports for statistical signal detection) benefits from closer alignment with FDA and EMA signal databases.
Specific priority gaps include: medical device post-market clinical follow-up (highlighted by the mesh implant and cardiac device controversies); long-term safety monitoring for conditionally approved medicines leaving provisional status; and pharmacovigilance integration with digital health record data, which the TGA's Digital Health Strategy has flagged but not yet operationalised.
The Digital Therapeutics Regulatory Gap
Digital therapeutics — software applications that deliver evidence-based therapeutic interventions for clinical conditions — represent the fastest-growing category of health intervention for which Australian regulation is least fit-for-purpose.
The TGA regulates software as a medical device (SaMD) under the existing medical device framework, with risk-tiered classification (Classes I through III and AIMD equivalent) mapped from the International Medical Device Regulators Forum (IMDRF) SaMD guidance. The framework is, in principle, sufficient for diagnostic and monitoring software. It is less adequate for prescription digital therapeutics (PDTs) — software products that require clinical prescription, deliver therapeutic content, and generate outcomes data — because the clinical evidence requirements, comparative efficacy standards, and prescription integration mechanisms used for pharmaceutical products do not translate cleanly to software.
Australia has no PDT-specific pathway analogous to the FDA's Breakthrough Device designation for software, nor the EMA's guidance on adaptive digital pathways. The TGA's 2024 AI and Machine Learning in Medical Devices guidance document is a positive step, but it addresses device safety and algorithmic transparency rather than the clinical evidence standard and prescribing integration needed for therapeutic software.
The consequences of this gap are practical: Australian patients cannot access several evidence-based PDTs that are FDA-cleared and clinically validated for conditions including insomnia, substance use disorder, and ADHD because the products are not listed on the ARTG, and their sponsors have not pursued TGA registration given regulatory pathway uncertainty and the absence of PBS reimbursement mechanisms for software therapeutics. The Australian Digital Health Agency and the TGA have both acknowledged the gap; a joint consultation paper is expected in the second half of 2026. The Coalition's view is that this should be accelerated.
TGA Consultation Processes: Structural Accessibility Issues
The TGA conducts public consultation on scheduling proposals (through the Advisory Committee on Medicines Scheduling, ACMS), on device classification, and on regulatory guidance documents. These processes are formally open to all stakeholders. In practice, their accessibility to patient advocacy groups, smaller sponsors, and community organisations is limited by several structural factors.
Comment period lengths. Most TGA consultation periods are 30 to 60 days. For patient advocacy groups with limited administrative capacity, preparing a substantive evidence-based submission in this timeframe is difficult.
Technical complexity. Scheduling consultation documents assume familiarity with the SUSMP, the TGA's risk-benefit framework, and pharmaceutical chemistry — a level of expertise not widely distributed in the community sector.
Advisory committee composition. The ACMS and its sister committee the Advisory Committee on Medical Devices (ACMD) are composed primarily of clinicians, pharmacologists, and industry representatives. Patient and community voices have a smaller structural presence than in equivalent FDA and EMA advisory processes, where patient representatives are formal committee members with voting rights in some contexts.
The TGA's 2025 Stakeholder Engagement Strategy committed to improving accessibility. Implementation has been uneven. The Coalition's position is that patient representatives should hold formal standing positions — not merely observer status — on ACMS and ACMD, and that consultation periods for significant scheduling decisions should be a minimum of 90 days with supported participation funding for community organisations.
Reform Proposals for 2027
The Coalition for Better Health endorses the following reform priorities for implementation in the 2027 parliamentary term.
1. Accelerated Review for Priority Medicines
The TGA should establish a formal Priority Review designation — analogous to the FDA Priority Review and the EMA PRIME scheme — for medicines that address serious or life-threatening conditions where no adequate therapy exists, or where the product demonstrates a substantial improvement over existing therapy. Priority Review designation should trigger: a 120-business-day evaluation target (reduced from 175); a dedicated TGA case manager; eligibility for rolling submission; and concurrent PBAC pre-submission consultation. This does not require legislative change; it is achievable through regulatory guidance and internal TGA resourcing.
2. Mutual Recognition Expansion
Australia currently treats FDA and EMA approvals as supporting evidence under Category 2, but does not adopt them as determinative. The TGA should expand its mutual recognition or reliance arrangements to allow expedited registration — within 60 to 90 days — for products approved by the FDA or EMA under their respective breakthrough or accelerated pathways, following a streamlined TGA safety and local labelling review. The UK MHRA's International Recognition Procedure, introduced in 2024, is the model: it has demonstrably reduced approval timelines without compromising safety outcomes.
3. Biosimilar Prescriber Switching Program
The Commonwealth should fund a national prescriber education and switching program for biosimilars in high-volume PBS categories, modelled on the NHS England Commissioning Framework for biosimilars. The program should include: updated TGA interchangeability guidance for each approved biosimilar category; a PBS price reduction mechanism that passes a portion of savings to funding for novel medicines access; and rheumatology, gastroenterology, and oncology society endorsement of switching protocols. Target: lift biosimilar penetration in eligible categories from approximately 60% to 80% within two years.
4. Compounding Pharmacy Regulatory Framework Post-Rescheduling
The TGA and Department of Health should jointly publish a compounding pharmacy implementation framework for Schedule 4 peptides, addressing: appropriate prescribing indications and documentation requirements; TGO 107 compliance pathways for compounding pharmacies of different scale; and a quality assurance pilot program allowing accredited compounding pharmacies to demonstrate conformance with a simplified testing protocol for low-risk peptide substances. The alternative — continued regulatory silence — predictably drives demand toward unregulated supply.
5. Digital Therapeutics Regulatory Pathway
The TGA should publish, by mid-2027, a dedicated regulatory pathway for prescription digital therapeutics, encompassing: a clinical evidence standard (randomised controlled trials or equivalent real-world evidence with validated outcomes measures); a product classification scheme distinguishing PDTs from monitoring and wellness software; and a PBS listing mechanism for cost-effective PDTs. The joint TGA-ADHA consultation paper expected in late 2026 should be the foundation, not the endpoint.
6. Post-Market Surveillance Modernisation
The TGA should: redesign the DAEN reporting interface to reduce time-to-report below five minutes for standard adverse event types; establish a formal data-sharing agreement with the FDA and EMA for signal exchange on commonly registered products; and initiate a pilot program linking PBS dispensing data with DAEN reports to improve signal detection for medicines with low absolute adverse event volumes. Legislative amendments to the Therapeutic Goods Act 1989 may be required to authorise the data linkage component; the Department of Health should prioritise this in the 2027 budget cycle.
7. Community Participation in Advisory Committees
The TGA should establish formal patient and community representative positions — minimum two per committee — on the ACMS and ACMD, with remuneration and supported participation funding. Consultation periods for significant scheduling decisions (including Schedule 4 and Schedule 8 transitions) should be extended to a minimum of 90 days. The TGA's international engagement on these issues — with the FDA's Patient-Focused Drug Development initiative and the EMA's Patients' and Consumers' Working Party — should be formalised and published.
Conclusion
The TGA's reform agenda for 2027 is not about weakening safety standards. Australia's medicines regulator has a strong safety record and an internationally respected technical workforce. The reform agenda is about reducing the structural delays and regulatory gaps that cause Australians to wait longer than comparable OECD populations for access to evidence-based medicines, that leave compounding pharmacy and digital therapeutics in regulatory ambiguity, and that limit community voice in decisions that directly affect patient access.
Accelerated review pathways, expanded mutual recognition, biosimilar switching programs, a compounding regulatory framework, a digital therapeutics pathway, modernised post-market surveillance, and meaningful community participation in advisory processes — none of these is technically complex. Each is achievable within existing constitutional and budgetary frameworks. What is required is political will and administrative prioritisation.
The Coalition for Better Health's view is that medicines access is a health equity issue. Every month of regulatory delay is a month during which Australians with serious illness cannot access treatments available to patients in the United States, the United Kingdom, or Europe. The 2027 reform window is an opportunity to close that gap in a substantive and durable way.
This analysis represents the Coalition for Better Health's policy advocacy position, based on publicly available data from AIHW, the Department of Health, and parliamentary submissions.