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TGA

The Therapeutic Goods Administration (TGA) is the Australian Government agency tasked with regulating the safety, quality, efficacy, and advertising of therapeutic goods, including medicines, medical devices, biologicals, and related products, to safeguard public health. Established in 1989 under the Therapeutic Goods Act as part of the Department of Health and Aged Care, it maintains the Australian Register of Therapeutic Goods (ARTG) and employs a risk-based framework grounded in clinical and scientific evidence for pre-market assessments and post-market surveillance.^[1] The TGA evaluates applications for product registration, monitors adverse events through mandatory reporting, and enforces compliance via inspections and recalls, regulating over 100,000 listed items annually. Key milestones include its role in harmonizing national standards post-federation-era regulations and expedited approvals during the COVID-19 pandemic, which facilitated rapid market access to vaccines while drawing scrutiny for transparency in data handling and potential underreporting of adverse effects.^[1]^[2] It has pursued international alignment, such as a proposed joint agency with New Zealand that was abandoned in 2010 due to concerns over sovereignty and regulatory rigor.^[1] Notable achievements encompass strengthened oversight of emerging categories like vaping products and AI-enabled devices, alongside performance targets met in 2023-24 for priority medicine reviews within 150 working days.^[2] However, the agency has encountered controversies, including allegations of industry capture in fee-dependent operations and decisions like the 2023 rescheduling of MDMA and psilocybin for psychiatric treatments amid lobbying influences and questions about trial evidence quality.^[3]^[4] Reviews have highlighted inconsistencies in advertising enforcement and calls for enhanced transparency to counter perceptions of bias in institutional decision-making.^[5] These issues underscore ongoing debates about balancing innovation with empirical scrutiny in regulatory science.^[6]

History

Establishment and Legislative Foundations

The Therapeutic Goods Administration (TGA) was formally established on 15 February 1991, when the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 came into effect, creating a centralized national regulatory authority for therapeutic goods in Australia.^[1] The Act, which received royal assent on 14 June 1989, aimed to implement a uniform national system of controls over the quality, safety, efficacy, and timely availability of therapeutic goods, leveraging Commonwealth constitutional powers related to imports, exports, and interstate trade.^[7] This legislation marked a shift from the prior fragmented regulatory landscape, where therapeutic goods oversight was primarily managed at the state and territory levels, supplemented by limited federal acts such as the Therapeutic Substances Act 1953 and the Therapeutic Goods Act 1966.^[1] Prior to 1991, federal involvement had evolved gradually through bodies like the National Health and Medical Research Council (NHMRC) and committees such as the Australian Drug Evaluation Committee (ADEC, established 1963), which handled pre-market assessments and adverse reaction monitoring, but lacked a cohesive national framework.^[1] The 1989 Act consolidated these functions under the TGA, incorporating existing advisory mechanisms like ADEC and the Adverse Drug Reactions Advisory Committee (ADRAC, formed 1970) into a risk-based regulatory approach, while requiring states to adopt complementary legislation for full enforcement uniformity—achieved variably, with New South Wales and Tasmania aligning by 2007.^[1] The establishment also introduced the Australian Register of Therapeutic Goods (ARTG), a public database for approved products, enabling systematic pre-market evaluation and post-market surveillance.^[1] The legislative foundations emphasized evidence-based standards derived from international benchmarks, such as those from the World Health Organization, while addressing domestic concerns like manufacturing quality and contamination risks identified in inspections during the 1980s.^[1] This structure positioned the TGA within the Department of Health (later restructured), granting it powers to classify goods, enforce compliance, and prohibit unsafe products, thereby prioritizing public health over decentralized inconsistencies that had persisted since pre-federation colonial regulations.^[1]^[7]

Expansion and Key Reforms

Following its establishment under the Therapeutic Goods Act 1989, which came into effect on 15 February 1991, the Therapeutic Goods Administration (TGA) expanded its regulatory scope to encompass a broader array of therapeutic goods beyond traditional pharmaceuticals, including medical devices, complementary medicines, and biologicals. This growth was driven by legislative amendments and responses to emerging public health needs, such as the formal inclusion of medical devices through risk-based classification under the 2002 Medical Devices Amendments, which aligned Australian standards with international frameworks like those of the European Union. By 1999, the creation of the Office of Complementary Medicines further extended oversight to non-prescription herbal and nutritional products, with the Complementary Medicines Evaluation Committee gaining statutory powers to evaluate efficacy and safety claims.^[1] The TGA's operational expansion included enhanced clinical trial oversight, with the Clinical Trial Notification (CTN) scheme commencing in May 1991 to streamline low-risk trials, building on the earlier Clinical Trial Exemption (CTX) scheme introduced on 1 July 1987 for higher-risk evaluations. Export regulation was formalized in 2000, covering unapproved goods and fresh blood components, while the 1998 launch of the Orphan Drug Program designated 124 products by April 2007 to incentivize development for rare diseases. Infrastructure growth supported this, including the Electronic Lodgement Facility (ELF) in 1996 for digital submissions, upgraded in 1998 and 2003 to handle increasing volumes. Staff and testing capacities also scaled, with specialized branches like the Conformity Assessment Branch established in 1997 and the Regulatory Compliance Unit operational by 2007, comprising 10 personnel focused on investigations.^[1] Key reforms emphasized post-market safety and international harmonization. The 2003 Therapeutic Goods Amendment Act (No.1), enacted in response to the Pan Pharmaceuticals recall scandal involving contaminated supplements, imposed stricter sponsor and manufacturer accountability, including mandatory adverse event reporting and GMP compliance audits. Civil penalties were introduced in 2005 to deter non-compliance, replacing reliance on criminal sanctions alone. Internationally, Australia's 1997 Mutual Recognition Agreement with the EU facilitated device approvals, complemented by membership in the Pharmaceutical Inspection Co-operation Scheme (PIC/S) from 1993, which standardized manufacturing inspections across 50+ members. A proposed joint agency with New Zealand, formalized by treaty in 2003, aimed to unify regulations but was postponed in 2007 due to implementation challenges. These measures collectively reduced approval delays and enhanced evidence-based decision-making, though critics noted persistent bottlenecks in high-risk biologicals approvals.^[1]^[8]

Response to Major Health Crises

The Therapeutic Goods Administration (TGA) has played a central role in Australia's response to pandemics by expediting therapeutic goods approvals, monitoring supply chains, and enforcing regulations against unproven claims. During health emergencies, the TGA leverages provisional registration pathways and special access schemes to facilitate rapid market entry of critical products while maintaining safety oversight.^[9]^[10] In the 2009 H1N1 influenza pandemic, the TGA approved the registration of Panvax, a monovalent vaccine against Pandemic (H1N1) 2009 influenza, on September 18, 2009, enabling its inclusion in the national vaccination program that commenced on September 30, 2009, and continued until December 31, 2010.^[11]^[12] This approval supported broader public health efforts to vaccinate priority groups amid global spread that affected over 122 countries within six months of emergence.^[13] The TGA's most extensive crisis response occurred during the COVID-19 pandemic, declared a public health emergency in early 2020. It introduced urgent legislative instruments and guidance to address manufacturing and supply disruptions, including monitoring for medicine shortages that could arise from global demand surges, though none were directly attributed to COVID-19 as of March 6, 2020.^[14]^[10] The agency regulated personal protective equipment (PPE) by inferring intended medical uses from labeling and advertising, prioritizing rapid assessments for items like respirators to ensure particle filtration efficiency amid shortages.^[15]^[16] For COVID-19 vaccines, the TGA granted provisional approvals following rigorous evaluations of safety, quality, and efficacy data. Comirnaty (Pfizer-BioNTech) received provisional approval on January 25, 2021, for individuals aged 16 and older, marking Australia's first authorized COVID-19 vaccine.^[17] Subsequent approvals included Spikevax (Moderna) on August 9, 2021, for those aged 18 and older, with expansions to younger age groups such as 12-17-year-olds later that year; and Nuvaxovid (Novavax) on January 19, 2022.^[18]^[19] The TGA also issued warnings against complementary medicines and disinfectants falsely promoted for prevention or treatment, enforcing compliance to curb misinformation.^[10] Post-approval, laboratories supported national testing and surveillance efforts.^[20] These responses highlighted the TGA's adaptive regulatory mechanisms, such as provisional determinations issued prior to full applications to streamline emergency authorizations, though inquiries have noted calls for enhanced quality assurance in vaccine testing protocols.^[9]^[21]

Organizational Structure and Governance

Leadership and Decision-Making Bodies

The Therapeutic Goods Administration (TGA) operates under the leadership of the Deputy Secretary of the Health Products Regulation Group (HPRG), a division of the Australian Government Department of Health, Disability and Ageing, with Professor Tony Lawler serving in this role since mid-2023, succeeding Professor John Skerritt.^[22]^[23] The Deputy Secretary oversees strategic direction, regulatory policy, and operational execution for therapeutic goods, including medicines, medical devices, and biologicals. Supporting this position is the Chief Medical Adviser, Professor Robyn Langham, who provides clinical and scientific guidance on complex health product evaluations and public health risks.^[22] Operational decision-making is decentralized across key divisions led by First Assistant Secretaries, each responsible for specific regulatory functions: Dr. Bridget Gilmour-Walsh heads the Regulatory Legal Services Division, handling legislation, compliance disputes, and legal advice; Nick Henderson leads the Medicines Regulation Division, focusing on evaluation, authorization, and monitoring of prescription and over-the-counter medicines; Tracey Duffy directs the Medical Devices and Product Quality Division, overseeing device conformity assessments and manufacturing quality controls; and Chris Bedford manages the Regulatory Practice and Support Division, which supports policy development, stakeholder engagement, and digital transformation initiatives.^[22] These executives report to the Deputy Secretary and contribute to delegate-level decisions authorized under the Therapeutic Goods Act 1989, ensuring alignment with statutory requirements for safety, quality, and efficacy.^[22] In addition to internal executive structures, the TGA relies on seven statutory advisory committees established under Part 6 of the Therapeutic Goods Regulations 1990 to inform decision-making on technical and scientific matters.^[24] These committees, appointed by the Minister for Health and comprising independent experts in fields such as pharmacology, toxicology, and consumer health, provide non-binding recommendations on issues including medicines scheduling, therapeutic goods advertising, and post-market safety reviews.^[24] Membership requires disclosure and management of conflicts of interest, with advice integrated into the TGA's risk-proportionate framework to support delegate approvals, cancellations, or variations of product registrations.^[24] Examples include the Advisory Committee on the Safety of Vaccines (ACSOV) for vaccine-related risks and the Medicines Shortages Information Initiative Committee (MSIIC) for supply disruptions, ensuring decisions reflect evidence-based expertise rather than solely administrative processes.^[24]

Internal Departments and Operations

The Therapeutic Goods Administration (TGA) operates within the Health Products Regulation Group (HPRG) of the Australian Government Department of Health, Disability and Ageing, comprising several specialized divisions focused on regulatory evaluation, monitoring, compliance, and support functions.^[22] These divisions are led by first assistant secretaries and include branches that handle specific operational tasks, such as product assessments, safety surveillance, laboratory testing, and policy implementation, with an emphasis on collaboration across internal teams and external stakeholders to align with HPRG's public health priorities.^[22] The Medicines Regulation Division oversees the evaluation and authorization of medicines, including prescription, over-the-counter, and complementary products. Its branches conduct scientific reviews for efficacy and safety, manage pharmacovigilance to monitor adverse events and medicine shortages, and provide regulatory support for clinical trials and international access schemes, processing applications through risk-based pathways to ensure timely market entry while upholding quality standards.^[22] The Medical Devices and Product Quality Division regulates medical devices, diagnostics, and manufacturing processes, with branches responsible for device authorizations, post-market surveillance, and quality assessments via TGA laboratories that perform chemical, microbiological, and stability testing on samples to verify compliance with standards. This division also enforces manufacturing good practices and coordinates recalls, integrating data from inspections and audits to mitigate risks throughout the product lifecycle.^[22]^[25] The Regulatory Practice and Support Division provides operational backbone through policy development, digital transformation, and enforcement activities, incorporating the Office of Drug Control for scheduling controlled substances and medicinal cannabis, alongside branches for vaping regulation enforcement, stakeholder engagement, and compliance investigations. This division facilitates agile regulatory practices, including digital tools for submissions and data analytics for trend identification.^[22] Supporting these are cross-cutting functions like the Regulatory Legal Services Division, which delivers legal advice, freedom of information handling, and litigation support to underpin enforcement and dispute resolution across TGA operations. Internal operations emphasize evidence-based decision-making, with divisions employing multidisciplinary teams of scientists, lawyers, and regulators to process over thousands of annual applications and surveillance reports, adapting to emerging risks such as supply chain disruptions through integrated risk management frameworks.^[22]

Core Functions and Regulatory Powers

Pre-Market Approval Processes

The Therapeutic Goods Administration (TGA) mandates pre-market approval for therapeutic goods intended for supply in Australia, primarily through inclusion in the Australian Register of Therapeutic Goods (ARTG), to verify quality, safety, and efficacy based on risk classification.^[26] Processes vary by product type, with medicines divided into listed (lower risk, self-assessed by sponsors) and registered (higher risk, TGA-evaluated) categories, while medical devices rely on conformity assessment procedures aligned with international standards like those from the International Medical Device Regulators Forum.^[27] Biologicals are regulated as registered medicines with enhanced manufacturing oversight, and export-only goods may bypass full ARTG entry if not supplied domestically but require manufacturing licenses. Applications are submitted via the TGA Business Services (TBS) portal, requiring sponsors to provide comprehensive dossiers in formats such as the Common Technical Document (CTD) for medicines.^[28] For prescription medicines seeking registration, the process encompasses eight phases: pre-submission planning (including a Pre-Submission Planning Form lodgement on the 1st-15th of the month), submission of the full dossier, first-round assessment (triggering a Section 31 request for further information if needed), sponsor response, second-round assessment, expert advisory committee review (e.g., by the Advisory Committee on Medicines or Vaccines), decision-making, and post-decision activities like labeling finalization.^[29] The average timeframe is 330 calendar days, excluding sponsor response periods, with data requirements including nonclinical studies, clinical trials, bioequivalence data, and quality controls; incomplete submissions delay processing.^[29] Priority review shortens this to 150 working days for medicines addressing unmet needs or serious conditions, while the provisional approval pathway permits time-limited registration (up to two years, renewable) based on preliminary evidence of substantial benefits outweighing risks, followed by confirmatory data.^[30]^[31] Listed medicines, suitable for low-risk indications like complementary therapies, undergo sponsor self-assessment against pre-approved ingredients and claims, without TGA pre-market evaluation of efficacy or individual safety dossiers, though quality and labeling compliance must be certified.^[32] Sponsors submit applications electronically, and upon validation, the product is entered into the ARTG if criteria are met, typically within days, but assessed listed medicines for secondary indications require TGA review of supporting evidence.^[33] Medical devices and in vitro diagnostics (IVDs) follow a risk-based classification (Class I low risk to Class III/AIMD high risk), necessitating manufacturer evidence of conformity to the Essential Principles via Quality Management System certification and technical documentation.^[27] For Class I non-sterile devices, sponsors self-declare conformity; higher classes require TGA audit, certification, or acceptance of equivalent overseas assessments (e.g., from EU Notified Bodies under mutual recognition).^[34] Applications include preliminary assessment, potential audits (selected via risk criteria like novel technology), and ARTG inclusion upon approval, with timeframes varying but targeted for efficiency post-2019 reforms; evidence must demonstrate safety and performance through clinical data where applicable.^[35]^[36] Biological therapeutic goods, such as vaccines and gene therapies, integrate registered medicine processes with stringent Good Manufacturing Practice (GMP) compliance, including facility audits and risk management plans, evaluated pre-market for manufacturing consistency and biological risks.^[37]

Classification and Scheduling of Goods

The Therapeutic Goods Administration (TGA) classifies therapeutic goods into categories such as medicines, medical devices, and biologicals, with further risk-based subclassifications determining pre-market evaluation requirements and post-market controls. Medicines are primarily divided into registered and listed categories: registered medicines undergo full TGA assessment for quality, safety, and efficacy, enabling broader therapeutic claims and suited to higher-risk products like prescription pharmaceuticals, while listed medicines are evaluated only for quality and safety, with claims limited to low-risk indications, encompassing most complementary medicines and certain over-the-counter products containing pre-approved ingredients.^[38] Scheduling, administered through the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP, also known as the Poisons Standard), provides a national framework for classifying active substances and chemicals into Schedules 1 through 10 based on potential harm, thereby regulating their availability, labelling, and supply restrictions to safeguard public health. These schedules are enforced via state and territory legislation, with examples including Schedule 2 for pharmacy medicines available without prescription under pharmacist advice, Schedule 4 for prescription-only medicines requiring medical authorization, and Schedule 8 for controlled drugs subject to strict monitoring due to abuse potential; exemptions and appendices allow nuanced applications, such as unscheduled low-risk substances for general sale. The SUSMP is periodically updated, with the latest version reflecting ongoing scheduling decisions informed by risk assessments and stakeholder input.^[39]^[40] Medical devices are classified by inherent risk level into four classes—I (lowest risk, e.g., non-sterile bandages), IIa (short-term moderate risk), IIb (medium to longer-term risk), and III (highest risk, e.g., implants affecting vital functions)—governed by specific rules considering factors like invasiveness, duration of use, and active components, which dictate the scope of conformity assessment and manufacturer evidence requirements for Australian Register of Therapeutic Goods (ARTG) inclusion. Sponsors must accurately declare the class during application, as misclassification can lead to non-refundable rejections and heightened regulatory scrutiny.^[41] Biologicals, encompassing human cell- and tissue-based therapies, are stratified into four classes by risk: Class 1 (lowest, e.g., minimally manipulated tissues under accredited oversight, no pre-market GMP required), Class 2 (homologous use with minimal manipulation), Class 3 (non-homologous or more manipulated for homologous use), and Class 4 (highest, e.g., gene-modified cells or xenografts), with Classes 1 and 4 mandatorily listed in Schedule 16 of the Therapeutic Goods Regulations for additional controls, while all require ARTG entry. This dual classification-scheduling approach ensures alignment with international standards like those from the International Medical Device Regulators Forum, balancing innovation with safety.^[42]

Post-Market Monitoring and Surveillance

The Therapeutic Goods Administration (TGA) oversees post-market monitoring and surveillance to evaluate the continued safety, quality, efficacy, and performance of therapeutic goods listed on the Australian Register of Therapeutic Goods (ARTG), identifying risks undetected in pre-market assessments through real-world data analysis.^[43] This encompasses pharmacovigilance for medicines, biologicals, and vaccines, alongside vigilance and post-market surveillance for medical devices, with sponsors bearing primary responsibility for reporting and maintaining systems to detect issues.^[44]^[45] A core component is the Database of Adverse Event Notifications (DAEN), an online repository launched in 2013 that publishes de-identified reports of suspected adverse events for medicines (including vaccines and biologicals) and medical devices received by the TGA since 2012 and 2015, respectively.^[46]^[47] The DAEN enables public access to searchable data, supporting transparency and aiding the TGA in signal detection—defined as potential safety concerns arising from patterns in reports—via statistical and qualitative analysis.^[48] Sponsors and healthcare professionals report events through dedicated portals, with the TGA using this data to assess benefit-risk balances and trigger regulatory responses like safety updates or withdrawals.^[49] For medicines, sponsors must establish and maintain a pharmacovigilance system, nominating an Australian contact person within 15 days of ARTG entry, and report all serious adverse reactions (e.g., those causing death, hospitalization, or disability) occurring in Australia within 15 calendar days using formats like the CIOMS-1 form or electronic systems.^[44] Significant safety issues require notification within 72 hours, while other concerns follow within 30 days; literature-sourced serious events must also be reported within 15 days with references.^[44] The TGA's risk-based Pharmacovigilance Inspection Program, updated as of February 19, 2025, verifies sponsor compliance through audits, focusing on reporting accuracy and system robustness to mitigate post-approval risks.^[50] Medical device surveillance mandates sponsors to implement post-market surveillance plans, particularly for Class IIb, III, and IM devices, including annual summary reports on safety and performance data to enable early issue detection.^[51] Adverse events—such as incidents causing or risking death, serious injury, or device malfunctions compromising safety—must be reported via the Medical Device Incident Reporting (MDIR) system, allowing the TGA to monitor real-world performance and trends.^[52] Initial reports for serious Australian incidents are required within 10 working days, with follow-up investigations and final reports submitted as specified, up to 120 calendar days for resolution.^[53]^[54] The TGA supplements reporting with proactive measures, including post-market reviews of selected devices to confirm ongoing compliance and risk profiles, selectable anytime based on emerging data or complaints.^[55] Enhancements implemented since 2022 include a dedicated database with a sponsor compliance dashboard for analytics-driven targeting, while the March 5, 2025, Procedures for Recalls, Product Alerts, and Communications (PRAC) standardize responses into four recall classes and five resolution phases, replacing prior guidelines to streamline defect handling.^[56]^[57] These mechanisms collectively enable risk mitigation through alerts, cancellations, or international harmonization under frameworks like the International Medical Device Regulators Forum.^[45]

Enforcement and Compliance Mechanisms

Inspection and Auditing Procedures

The Therapeutic Goods Administration (TGA) conducts inspections and audits to enforce compliance with Good Manufacturing Practice (GMP) standards for medicine manufacturers, employing a risk-based approach that prioritizes sites based on factors such as compliance history and product risk.^[58] These inspections typically involve a multidisciplinary team reviewing quality systems, documentation, and operations, lasting 1 to 5 days, with initial assessments being especially comprehensive to establish baseline compliance.^[58] From 1 July 2024, TGA implemented temporary arrangements for GMP surveillance inspections of domestic and overseas medicine manufacturers, extending certificate validity periods and adjusting frequencies to balance oversight with resource constraints amid global supply challenges.^[59] For medical devices and related manufacturing, TGA performs Quality Management System (QMS) audits as part of conformity assessment certification, evaluating adherence to essential principles of safety and performance through onsite, remote, or desktop methods.^[60] Audit procedures include pre-audit preparation, opening and closing meetings, evidence collection via interviews and observations, classification of findings as major or minor nonconformities, and post-audit close-out requiring manufacturer responses within 4 weeks and full resolution typically within 12 weeks.^[60] Noncompliance may trigger enforcement actions such as certificate suspension or cancellation.^[60] Good Clinical Practice (GCP) inspections target clinical trials for medicines and devices, categorized as routine (risk-based, scheduled), triggered (for cause, addressing specific concerns like safety signals), or unannounced (when pre-notification risks compromising integrity).^[61] These 1- to 3-day assessments, conducted in-person or hybrid, focus on participant protection, protocol adherence, documentation integrity, investigational product handling, and trial management, with sponsors required to maintain ongoing readiness including staff availability and record access.^[61] Pharmacovigilance inspections evaluate sponsors' compliance with risk management and adverse event reporting obligations through on-site interviews and document reviews, often triggered by signals of inadequate pharmacovigilance systems.^[50] Across all procedures, TGA inspectors document findings in reports, mandate corrective actions, and may escalate to licensing conditions or legal enforcement if deficiencies persist.^[58]^[60]

Penalties and Legal Actions

The Therapeutic Goods Administration (TGA) imposes penalties under the Therapeutic Goods Act 1989 for breaches such as unlawful supply, advertising, or importation of therapeutic goods, with options including infringement notices, civil penalties, and criminal prosecutions. Infringement notices, issued for less severe contraventions, require payment of fixed financial penalties, typically ranging from hundreds to thousands of dollars per breach, and serve as an alternative to court proceedings. Between mid-2023 and mid-2025, the TGA issued over 165 such notices, collecting more than $2.3 million in penalties, often targeting advertising violations or non-compliance with listing requirements.^[62]^[63]^[64] Civil penalty proceedings, pursued through the Federal Court, address serious or repeated violations and can yield multimillion-dollar fines. In a landmark case on 8 October 2024, Medtronic Australasia Pty Ltd was ordered to pay a record $22 million for supplying its Infuse Bone Graft Kit—a Class III medical device—without inclusion on the Australian Register of Therapeutic Goods (ARTG) from 2016 to 2021, despite awareness of the requirement; the court declared 1,135 contraventions, emphasizing the potential public health risks of unapproved spinal fusion products. Earlier, on 23 July 2019, Peptide Clinics Australia Pty Ltd and its director were fined $10 million in civil penalties for advertising prescription-only peptide hormones as performance enhancers, breaching restrictions on therapeutic goods promotion. In October 2023, Vapor Kings Pty Ltd and its director faced civil penalties for unlawfully advertising vaping products as therapeutic nicotine substitutes without approval.^[65]^[66]^[67]^[68] Criminal penalties apply to egregious cases, such as supplying goods likely to cause harm, carrying maximums of 5 years' imprisonment and fines up to $1.252 million for individuals or $6.26 million for corporations as of 2024. For example, in 2022, the TGA warned promoters of unapproved semaglutide compounds of potential criminal charges, including up to $888,000 fines for individuals, for illegal importation and supply amid shortages of approved versions. Prosecutions remain rarer than civil actions but underscore the TGA's escalation from administrative measures to judicial remedies when voluntary compliance fails.^[69]^[70]^[71]^[72]

International Cooperation and Harmonization

The Therapeutic Goods Administration (TGA) pursues international cooperation to align Australian regulations with global standards, reducing duplication and enhancing efficiency in evaluating therapeutic goods. This includes adopting international scientific guidelines after internal and external consultations to ensure consistency with domestic legislation, with deviations justified only where necessary.^[73] For pharmaceuticals, the TGA incorporates guidelines from the International Council for Harmonisation (ICH), such as the ICH E6(R3) on Good Clinical Practice principles, expected for adoption with annotations by January 2026, and the EU-aligned ICH Guideline for Good Clinical Practice (CPMP/ICH/135/95).^[73]^[74] These adoptions apply to prescription medicines, over-the-counter products, and complementary medicines, facilitating reliance on assessments from comparable regulators like the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA).^[73] In medical device regulation, the TGA serves as a founding member of the International Medical Device Regulators Forum (IMDRF), formed in 2011 to build on prior Global Harmonization Task Force efforts, and actively participates in its Management Committee alongside regulators from the EU, U.S., Canada, Japan, and others.^[75] This involvement supports IMDRF's mission to accelerate harmonization and convergence of regulatory practices, including development of essential principles documents and unique device identification systems.^[75] The TGA also leverages conformity assessments from IMDRF peers, streamlining approvals for devices already authorized in jurisdictions like the EU or U.S., provided sponsors submit supporting evidence.^[76] Mutual recognition agreements (MRAs) further enable harmonization, particularly for good manufacturing practice (GMP). The TGA maintains an MRA with the European Union on GMP compliance for medicines, effective since 1998 and covering inspections and certifications.^[77] Similar arrangements exist with Canada for GMP mutual recognition, allowing recognition of each other's compliance efforts to optimize enforcement resources.^[78] Additionally, a cooperative agreement with the FDA, signed in 2018, facilitates exchange of GMP inspection information for human pharmaceuticals, protecting shared data under respective laws while aiding post-market surveillance.^[79] Through its 2021-2025 international engagement strategy, the TGA collaborates with the World Health Organization (WHO) on pharmacovigilance and regional capacity-building in Southeast Asia and the Pacific, supporting 18 countries via Australian Department of Foreign Affairs and Trade initiatives.^[80] It participates in the International Coalition of Medicines Regulatory Authorities (ICMRA) for work-sharing on high-priority issues, including COVID-19 responses, and the Access Consortium with Canada, Singapore, Switzerland, and the UK to coordinate oncology drug reviews under Project Orbis.^[80] Membership in the Pharmaceutical Inspection Co-operation Scheme (PIC/S) promotes GMP inspection harmonization, with the TGA adopting updated PIC/S guides excluding certain annexes as of 2023.^[80] These efforts prioritize evidence-based alignment to safeguard public health without compromising Australian-specific requirements.^[80]

Achievements and Positive Impacts

Enhancements to Public Safety

The Therapeutic Goods Administration (TGA) enhances public safety through comprehensive post-market surveillance, including the Database of Adverse Event Notifications (DAEN), which aggregates reports to detect safety signals and inform regulatory actions such as label updates or product withdrawals.^[46]^[48] In the 2023-24 financial year, the TGA processed 30,566 adverse event reports, including 13,085 related to vaccines, enabling investigations into emerging risks like those associated with GLP-1 receptor agonists (e.g., Ozempic), which prompted targeted label revisions to mitigate gastrointestinal side effects.^[81] Recalls and market withdrawals represent a core mechanism for risk mitigation, with the TGA coordinating 83 medicine recalls and 584 medical device recalls in 2023-24, primarily addressing labelling errors (33% of medicine cases) and mechanical defects (43% of device cases).^[81] These actions, supported by laboratory testing against national and international standards, have removed non-compliant products such as 9 foetal dopplers and 12 spinal cord stimulators from the Australian Register of Therapeutic Goods (ARTG), preventing potential harm from inaccurate performance or contamination risks, as seen in recalls of saline solutions tainted with Ralstonia pickettii bacteria through inter-agency collaboration.^[82]^[81] Recent reforms further bolster these efforts, including mandatory adverse event reporting by healthcare facilities under amendments to the Therapeutic Goods Act 1989 effective from March 2023, with hospital compliance required by March 2026 to capture device-related incidents more systematically.^[83] The introduction of the Procedure for Recalls, Product Alerts, and Corrections (PRAC) in March 2025 streamlines processes into four risk categories and five surveillance phases, enhancing speed and transparency in hazard response while incorporating digital tools like QR codes for consumer feedback.^[84] Additionally, enforcement actions seized over 650,000 illicit vaping products in 2023-24, curbing unregulated nicotine exposure, and a pilot Medical Devices Vigilance Program engaged over 500 sponsors to improve proactive monitoring.^[81] These measures contribute to sustained public confidence, as evidenced by 2024 stakeholder surveys where 72% of health professionals and 62% of consumers viewed the TGA's approach as effectively balancing safety with access to therapeutics.^[81] By prioritizing empirical signal detection over pre-market assumptions alone, such surveillance has iteratively refined product safety profiles, reducing incidences of undetected hazards post-approval.^[85]

Innovations in Regulatory Science

The Therapeutic Goods Administration (TGA) has pursued innovations in regulatory science primarily through its Health Products Regulation Group Regulatory Science Strategy 2020–2025, which focuses on enhancing capabilities to evaluate complex emerging technologies including gene therapies, cell and tissue therapies, 3D-printed medical devices, and software as a medical device.^[86] This framework establishes a Regulatory Scientist Forum for ongoing monitoring of technological trends and associated risks, alongside a dedicated database to catalog innovations and inform evidence-based decision-making.^[86] These tools enable proactive adaptation of evaluation methods, such as advanced risk assessment models tailored to decentralized manufacturing processes in 3D printing and the dynamic potency testing required for biologicals.^[86] A key advancement involves the integration of real-world evidence (RWE) into pharmacovigilance and approval processes, allowing the TGA to leverage observational data from post-market sources for safety signal detection and performance verification beyond controlled trials.^[87] Guidance published in April 2024 specifies criteria for RWE in medical device regulation, including data quality standards and its application to identify rare adverse events or long-term outcomes not captured in pre-market studies.^[87] Complementing this, a November 2021 report from stakeholder consultations endorses RWE alongside patient-reported outcomes to refine efficacy assessments, particularly for chronic conditions, while emphasizing rigorous validation to mitigate biases inherent in non-randomized datasets.^[88] In approving innovative therapeutics, the TGA employs fast-track pathways such as priority review—for applications addressing unmet needs in serious diseases, targeting 150-day evaluations—and provisional approval, which permits conditional market entry based on surrogate endpoints or preliminary clinical data, contingent on post-approval confirmatory evidence.^[89] These mechanisms, expanded through 2022 regulatory reforms, facilitate earlier access to treatments like advanced cell and gene therapies classified as biologicals, incorporating specialized frameworks for ex vivo genetic modifications and sterility assurance.^[8]^[90] By relying on international work-sharing with bodies like the European Medicines Agency, the TGA streamlines assessments without compromising causal evidence requirements, as demonstrated in harmonized evaluations of gene-modified cell products.^[91]

Global Influence and Collaborations

The Therapeutic Goods Administration (TGA) contributes to global regulatory harmonization as a regulatory member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), adopting guidelines such as the Good Clinical Practice standard while providing targeted national annotations to ensure applicability in Australia.^[92]^[93] This alignment facilitates consistent international standards for clinical trials, drug development, and safety assessments, with the TGA influencing guideline implementation through its participation in ICH assemblies and expert working groups.^[73] As a founding member of the International Coalition of Medicines Regulatory Authorities (ICMRA) since its establishment in 2013, the TGA engages over 40 member agencies in information sharing, crisis response, and regulatory science advancement, including coordinated efforts during outbreaks like COVID-19.^[94] In October 2025, TGA head Professor Tony Lawler was elected ICMRA Chair for a three-year term commencing post the annual meeting in Amsterdam, positioning the agency to lead global initiatives on supply chain resilience, emerging technologies, and harmonized approaches to public health threats.^[94] The TGA participates in Project Orbis, an initiative launched by the U.S. Food and Drug Administration (FDA) in 2019, enabling concurrent multinational reviews of oncology products with partners including Health Canada, the UK's Medicines and Healthcare products Regulatory Agency (MHRA), Singapore's Health Sciences Authority, and Brazil's ANVISA, which has expedited approvals for over 50 innovative cancer therapies as of 2024.^[95]^[96] Complementing this, the TGA is a core member of the Access Consortium—alongside regulators from Canada, Singapore, Switzerland, and the UK—focusing on joint evaluations of new chemical and biological entities to accelerate market access while leveraging shared expertise and reducing redundant assessments.^[97] Further extending its reach, the TGA holds mutual recognition agreements for Good Manufacturing Practice (GMP) compliance with entities like the European Union, Canada, and Switzerland, permitting reliance on overseas inspections to verify manufacturing quality without duplicating efforts.^[98] These collaborations, guided by the TGA's International Engagement Strategy 2021-2025, not only incorporate assessments from comparable overseas regulators (such as the FDA and European Medicines Agency) into Australian decisions but also export TGA's evaluations, fostering bidirectional influence on global standards for therapeutic goods safety and efficacy.^[80]^[99]

Criticisms and Controversies

Regulatory Delays and Overreach

The Therapeutic Goods Administration (TGA) has been criticized for delays in the approval of new medicines and medical devices, which industry stakeholders and international observers argue hinder timely patient access to innovative therapies. A 2023 report by the United States House of Representatives Committee on Energy and Commerce identified Australia as one of several countries where regulatory processes lag behind the FDA, resulting in Australian patients waiting an average of 591 days longer for subsidized access to new cancer treatments after initial approvals elsewhere.^[100] ^[3] These delays stem partly from the TGA's target of 150 working days for priority reviews, which, while met in some cases, often extend due to requirements for additional local safety and efficacy data not demanded by regulators like the FDA or EMA.^[8] For instance, between 2017 and 2021, the TGA's median approval time for new chemical entities was 255 working days, compared to 213 days for the FDA, with critics attributing the difference to bureaucratic lags in submission timing and TGA-specific evidentiary demands.^[3] Critics, including pharmaceutical industry groups, contend that these processes impose excessive caution, prioritizing risk aversion over speed and contributing to a "patient access gap" where therapies available overseas remain unavailable in Australia for months or years.^[100] Empirical analyses indicate that submission delays—companies often filing with the TGA after FDA or EMA due to resource constraints—compound review times, but TGA's insistence on independent verification rather than reliance on overseas approvals exacerbates the issue, potentially denying Australians earlier access to treatments with established global safety profiles.^[8] In medical devices, COVID-19-related backlogs in conformity assessments led to extended recertification timelines, with the TGA issuing guidance in 2020 to address lapsed certifications but acknowledging ongoing disruptions from EU MDR/IVDR transitions.^[101] Allegations of regulatory overreach center on the TGA's expansive enforcement powers and interpretive latitude, which some view as burdensome and disproportionate to risks. The 2003 Pan Pharmaceuticals scandal exemplified this, where the TGA suspended manufacturing licenses citing quality control failures and falsified data; while subsequent inquiries validated many actions, the regulator's raid and broad license cancellations prompted legal challenges, culminating in government compensation payments to avoid protracted litigation, raising questions about procedural proportionality.^[102] More recently, the TGA's intensified scrutiny of advertising for prescription-only cosmetics like injectables—prohibiting even indirect promotions—has drawn industry backlash for stifling legitimate marketing while low-risk products face heightened compliance costs, potentially deterring innovation without commensurate safety gains.^[103] Such measures, enforced through rising penalties (e.g., a 2024 AUD 1.5 million fine against Medtronic for supply violations), reflect a shift toward aggressive compliance but are criticized for creating a chilling effect on smaller sponsors, where the regulatory burden outweighs benefits for lower-risk goods.^[104]^[63] This approach, while rooted in statutory authority, has prompted calls for reforms to balance vigilance with efficiency, as excessive stringency may inadvertently favor established players over agile innovators.^[64]

Scandals Involving Product Safety Failures

In April 2003, the Therapeutic Goods Administration (TGA) suspended the manufacturing license of Pan Pharmaceuticals after an audit triggered by 87 adverse event reports linked to its Travacalm travel sickness tablets, including 19 hospitalizations primarily due to excessive drowsiness and other severe reactions.^[105]^[106] The investigation uncovered widespread good manufacturing practice (GMP) violations, such as falsified batch records, inadequate quality controls, and contamination risks across multiple product lines, leading to the recall of 1,546 complementary medicines representing about half of Australia's listed over-the-counter herbal and nutritional supplements at the time.^[106]^[107] This exposed systemic oversight gaps, as prior routine inspections had not detected the issues despite Pan's status as Australia's largest complementary medicine producer, resulting in a $2.5 billion industry crisis, supplier bankruptcies, and a Federal Court fine of $3 million against the company for manufacturing counterfeit pharmaceuticals and inflicting grievous bodily harm.^[108]^[109] In 2018, the International Consortium of Investigative Journalists' Implant Files investigation highlighted TGA approval failures for an experimental prosthetic arm device, the DEKA Arm, which was not cleared for human use in the United States but received conditional TGA inclusion based on incomplete overseas data.^[110] Implanted in an Australian veteran in a Sydney trial, the device malfunctioned shortly after surgery on November 25, 2013, causing nerve damage that left the patient unable to move his left arm, underscoring deficiencies in pre-market scrutiny for high-risk Class III devices where post-approval monitoring relied heavily on voluntary reporting.^[110] The case prompted calls for enhanced clinical trial oversight, as the TGA's reliance on manufacturer-submitted evidence without mandatory large-scale Australian trials contributed to the safety lapse.^[110] More recently, in September-October 2025, the TGA initiated recalls of at least 21 sunscreen products following independent laboratory tests by consumer group Choice revealing SPF levels significantly below advertised claims—some as low as 35% of stated protection—traced to a defective base formulation and questionable third-party testing by a single laboratory.^[111]^[112] Products from brands including Ultra Violette, Aspect, and others were pulled from shelves, with sales paused or voluntarily withdrawn, amid Australia's high skin cancer incidence where inadequate UV protection poses direct public health risks.^[113]^[114] The scandal, erupting after Choice's June 2025 report, criticized TGA post-market surveillance for not preempting the widespread use of unreliable testing data in sponsor applications, leading to heightened consumer anxiety and regulatory scrutiny over therapeutic goods claims verification.^[111]^[115] These incidents illustrate recurring patterns in TGA-regulated product failures, often involving delayed detection of manufacturing or efficacy defects until consumer reports or external audits intervene, despite mandatory GMP compliance and sponsor responsibilities under the Therapeutic Goods Act 1989.^[105]^[113] In the Pan case, subsequent government settlements exceeded $120 million, including $55 million to founder Jim Selim in 2008 and $67.5 million to affected customers in 2011, highlighting financial repercussions from regulatory lapses.^[116]^[108] Similarly, the sunscreen recalls prompted interim advice for consumers to discard affected items and seek alternatives, underscoring vulnerabilities in listed goods oversight where safety hinges on accurate sponsor declarations rather than proactive TGA testing.^[117]

Handling of COVID-19 Therapeutics and Vaccines

The Therapeutic Goods Administration (TGA) implemented a provisional registration pathway for COVID-19 vaccines to facilitate expedited access during the pandemic, accepting rolling clinical data submissions rather than complete dossiers upfront. The Pfizer-BioNTech mRNA vaccine received provisional approval on January 25, 2021, for individuals aged 16 and older, based on phase 3 trial results demonstrating 95% efficacy against symptomatic disease, followed by AstraZeneca's viral vector vaccine on February 8, 2021.^[118] Moderna and Novavax vaccines gained approval in August 2021 and January 2022, respectively, with conditions for ongoing safety monitoring.^[9] This framework, modeled on emergency use authorizations elsewhere, prioritized unmet need but required sponsors to provide full data within specified timelines, amid debates over whether abbreviated reviews compromised rigorous evaluation of rare adverse effects.^[119] Safety surveillance relied on the Database of Adverse Event Notifications (DAEN), a passive system supplemented by active monitoring via AusVaxSafety, yielding 111,348 adverse event following immunisation (AEFI) reports for COVID-19 vaccines in 2021—a rate of 271.4 per 100,000 doses—and 18,398 in 2022.^[120] Most events were mild and transient, such as injection-site pain or fatigue, but serious signals emerged: the TGA confirmed thrombosis with thrombocytopenia syndrome (TTS) as a rare risk of AstraZeneca (incidence ~2-3 per 100,000 doses, primarily in younger adults), prompting updated warnings by April 2021 and preferential mRNA recommendations for under-50s by June 2021.^[121] Myocarditis/pericarditis risks with mRNA vaccines (e.g., 1-5 cases per 100,000 doses in young males post-second dose) were acknowledged by July 2021, with no fatalities directly attributed in reports up to December 2022.^[122] Of 160 death reports in 2022, only one was assessed as likely vaccine-related, though causality assessments depend on temporal association and exclusion of alternatives. Critics, including affected individuals and legal advocates, have faulted the TGA for potential underreporting in passive systems, where events require proactive clinician submission, and for initially framing many post-vaccination symptoms (e.g., chronic fatigue, tinnitus) as unrelated or psychosomatic, delaying recognition of "long vax" conditions.^[123] A federal compensation scheme, covering only 10 predefined conditions with strict proof requirements, approved just 418 of 4,941 claims by its September 2024 closure, totaling $38.6 million, leaving thousands without recourse and no permanent framework.^[123] A class action lawsuit involving over 1,900 plaintiffs targets the TGA and government for alleged negligence in rollout oversight, claiming inadequate injury acknowledgment contributed to unaddressed harms.^[123] In therapeutics, the TGA restricted general practitioner prescribing of ivermectin for COVID-19 to specialists on September 10, 2021, after prescriptions surged 10-fold and veterinary imports spiked, citing meta-analyses showing no reliable efficacy and risks of toxicity from unverified sources.^[124] ^[125] Hydroxychloroquine faced similar off-label curbs, aligned with international bodies like the WHO deeming evidence insufficient for routine use. These measures, intended to curb misinformation-driven self-treatment, drew rebukes from dissenting clinicians and politicians who contended they stifled access to repurposed drugs amid early observational data suggesting potential benefits, later contested by larger trials.^[126] Restrictions on ivermectin eased in June 2023 after evidence reviews found no ongoing public health threat, prompting claims from ban opponents that the policy reflected premature overreach rather than evolving science.^[127] ^[128]

Allegations of Industry Capture and Lack of Transparency

The Therapeutic Goods Administration (TGA) has faced allegations of industry capture due to its funding model, under which approximately 96% of its operational costs are recovered through fees and charges levied on pharmaceutical and medical device sponsors. Critics, including health policy experts, argue that this financial dependence creates incentives for regulatory leniency, as rejection of applications could reduce future revenue streams, potentially prioritizing industry interests over rigorous oversight. For instance, following the transvaginal mesh scandal—where devices were approved based on 2008 evidence showing low complication rates but later linked to severe adverse events in thousands of women, prompting reclassification as high-risk in 2016 after 99 reports from 2012 to 2016—academics such as Dr. Wendy Bonython of the University of Canberra called the fee-for-service system unacceptable and urged a "clear break" between regulator and industry to mitigate capture risks. The TGA has countered that fees fund evaluations without refunds for rejected products, that spending decisions remain independent, and that no evidence of capture has emerged in over two decades of operation, a model also used by international counterparts to minimize taxpayer burden.^[129]^[130] Further concerns arise from the "revolving door" phenomenon, exemplified by the December 2023 appointment of former TGA CEO Professor John Skerritt—who led the agency from 2015 to 2023—to the board of Medicines Australia, the peak industry body representing pharmaceutical companies, as an independent director focused on advancing initiatives like mRNA technology frameworks. Such transitions have prompted accusations of conflicts of interest, with commentators arguing they erode public trust by blurring lines between regulation and industry advocacy, particularly given Skerritt's prior role in overseeing approvals for COVID-19 vaccines and therapeutics amid heightened scrutiny. The TGA maintains guidelines for managing conflicts in advisory committees, requiring declarations and recusal where necessary, but critics contend these measures insufficiently address post-employment influences in a system where industry fees dominate funding.^[131]^[132]^[133] Allegations of lack of transparency compound these issues, with a 2011 independent review commissioned by the TGA recommending enhanced public disclosure of regulatory processes, adverse event data, and post-market surveillance to better inform consumers and stakeholders, following submissions highlighting opaque handling of complaints and recalls. For example, a 2012 analysis of medical device incidents revealed patchy reporting, with up to 6,812 events logged by December 2011 but inconsistent classification and public details on recall types, impeding accountability. Additional criticisms include delayed or absent safety warnings for drugs, as noted in 2019 by medical groups questioning the TGA's communication on potential risks, and incomplete accessibility of advertising complaint outcomes, where 84% of 140 obesity product cases yielded "no result" in the database despite some delistings. While the TGA implemented reforms post-2011, such as improved online registers, ongoing audits like the 2023 Australian National Audit Office review of non-compliance management have underscored persistent gaps in visible enforcement and data sharing.^[134]^[135]^[136]^[137]

Recent Developments and Future Directions

2020s Reforms and Challenges

In response to identified gaps in medical device regulation, the Therapeutic Goods Administration (TGA) implemented a multi-phase action plan starting in 2021, focusing on pre-market reforms to streamline approvals for low-risk devices, enhanced post-market surveillance through mandatory reporting and audits, and updates to conformity assessment procedures to align with international standards.^[138] These changes included reclassifying certain devices and limiting mandatory audits from July 1, 2024, to high-risk categories only, aiming to reduce administrative burdens while prioritizing patient safety.^[139] By April 2024, the reforms emphasized improved safety, performance, and quality controls, with ongoing consultations on essential principles for device design.^[140] ^[141] Software as a Medical Device (SaMD) regulations advanced significantly, with full implementation of risk-based classification and approval pathways effective November 1, 2024, requiring sponsors to demonstrate clinical evidence for higher-risk software like diagnostic algorithms.^[142] Parallel efforts addressed artificial intelligence in medical devices through a 2025 review, confirming the adequacy of existing frameworks but recommending targeted updates to definitions of "manufacturer" and lifecycle management for adaptive AI systems, amid concerns over evolving software maintenance and validation.^[143] ^[144] These reforms responded to rapid technological growth but highlighted implementation challenges, including the need for new guidance on continuous learning algorithms.^[145] Pharmaceutical and therapeutic goods regulations saw amendments, such as the Therapeutic Goods Legislation Amendment effective October 1, 2025, modernizing testing protocols under the Therapeutic Goods Regulations 1990 to facilitate more efficient laboratory analysis and compliance verification.^[146] Evaluations of prior reforms, like the Prescribed List changes, revealed mixed outcomes by September 2025, with industry stakeholders noting insufficient impact on clinician prescribing flexibility and ongoing concerns over access to specialized medicines.^[147] Challenges persisted in approval timelines, with the TGA's review processes averaging longer durations than comparable regulators like the FDA or EMA, contributing to delays in market entry for new drugs—sometimes by 1-2 years—and limiting patient access to innovative therapies.^[8] ^[3] A 2021 inquiry into novel therapies underscored resource constraints and framework gaps for gene and cell treatments, prompting recommendations for accelerated pathways, though implementation lagged amid staffing shortages and submission backlogs.^[148] Critics, including international observers, argued that precautionary approaches, while safety-oriented, risked overregulation, as evidenced by Australia's lag in approving certain oncology and rare disease drugs approved overseas by 2022.^[8] Vaping product reforms from July 2024, restricting imports and enforcing special device arrangements, faced enforcement hurdles and supply disruptions, illustrating tensions between harm reduction and black-market proliferation.^[149] Overall, these issues reflected broader pressures on the TGA's capacity, with a 2020-2025 regulatory science strategy aiming to bolster internal expertise but struggling against rising submission volumes.^[86]

Emerging Issues in Digital Health and AI

The Therapeutic Goods Administration (TGA) regulates artificial intelligence (AI) applications in digital health when they function as software as a medical device (SaMD), such as tools for diagnosis, monitoring, or treatment prediction, requiring inclusion in the Australian Register of Therapeutic Goods (ARTG).^[150] These include AI-driven radiology analysis or melanoma detection apps, with manufacturers obligated to submit clinical and technical evidence demonstrating safety, performance, and applicability to Australian populations.^[150] Regulatory changes effective February 25, 2021, elevated many SaMD classifications to higher risk levels, mandating conformity assessments, though a transition period applied to pre-existing entries.^[151] In July 2025, the TGA released its review report, "Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence," affirming that the existing framework broadly accommodates AI but identifying gaps necessitating targeted reforms, with government approval for further development in January 2025.^[152] Key challenges include adaptive AI models, where algorithms evolve post-approval via machine learning, demanding ongoing evidence of sustained performance to prevent degradation from real-world data shifts.^[153] Post-market surveillance emerges as a critical issue, as AI devices may exhibit performance drift over time, requiring manufacturers to implement robust monitoring and reporting to detect biases or failures early, though current powers for compelling sponsor engagement in recalls and reviews are under scrutiny for enhancement.^[154] Transparency and explainability pose additional hurdles, particularly for opaque "black-box" AI and generative models like large language models used in clinical decision support, where regulators require disclosure of training data sources, validation methods, and decision rationales to enable independent verification.^[150] Synthetic data can supplement but not substitute real-world clinical evidence, raising concerns over generalizability and potential biases in datasets not representative of diverse Australian demographics.^[150] In digital health contexts, such as AI-enabled mental health apps or medical scribes, exclusions from regulation are being reevaluated, with proposals to reclassify certain tools into higher-risk categories to address unverified therapeutic claims.^[143] TGA's 2025 compliance priorities emphasize AI and software-based tools, including updates to definitions of "manufacturer" and "sponsor" to account for distributed AI development ecosystems, potentially involving third-party model providers.^[144] ^[155] Efforts toward international harmonization, aligned with International Medical Device Regulators Forum principles, aim to streamline approvals while mitigating risks like over-reliance on unproven AI in telehealth or wearables, balancing innovation with evidence-based safeguards.^[156] These developments underscore tensions between rapid AI adoption in digital health and the need for rigorous, lifecycle-based oversight to ensure causal reliability in clinical outcomes.

Ongoing Debates on Regulatory Balance

The Therapeutic Goods Administration (TGA) faces ongoing scrutiny over its ability to balance rigorous safety and efficacy evaluations against the need for timely access to innovative medicines and devices, with critics contending that prolonged approval timelines impose significant opportunity costs on patients. A 2024 study of FDA-approved breakthrough therapies revealed a median lag of 299 days from U.S. approval to TGA registration, underscoring Australia's slower pace compared to peer regulators despite targeted reforms like priority review pathways aiming for 150 working days.^[157]^[8] This delay has been linked to reduced patient access, particularly for cancer treatments, where pre-2011 regulatory-reimbursement sequencing contributed to 63-week gaps before parallel processing was introduced.^[158] Industry stakeholders, including Medicines Australia, argue that such inefficiencies reflect excessive administrative burdens and advocate for greater reliance on international data to streamline processes without undermining core protections.^[159] Proponents of the TGA's precautionary approach counter that independent assessments are essential to identify context-specific risks, such as varying pharmacogenomics in Australian populations or historical precedents of post-approval harms from expedited overseas authorizations. Rapid approvals carry inherent hazards, as evidenced by international cases requiring withdrawals due to unforeseen adverse events, justifying Australia's emphasis on comprehensive pre-market data over deference to foreign decisions.^[160] Reforms in the 2020s, including expanded regulatory reliance on FDA and EMA conformity assessments since 2022, represent incremental efforts to mitigate delays for extensions and low-novelty products while preserving scrutiny for high-risk innovations.^[8]^[161] These changes have facilitated faster market entry for select devices via mechanisms like 510(k) equivalence recognition, yet debates persist on their scope, with calls to extend similar flexibilities to unmet-need medicines under provisional pathways.^[162] Central to these discussions is the optimization of expedited routes, such as the TGA's Provisional Approval Pathway established in 2018 and refined post-2020, which permits conditional registration based on surrogate endpoints for serious conditions but requires post-market evidence generation. Consultations on further expedited options for novel prescription medicines highlight tensions between accelerating breakthroughs—potentially addressing unmet needs—and ensuring causal evidence of net benefit, with industry pushing for reduced data requirements akin to FDA accelerated approvals.^[163] Independent reviews have recommended targeted deregulation to excise redundant steps, estimating efficiency gains that could align TGA timelines more closely with global norms while upholding risk-based oversight.^[164] Critics from patient advocacy and public health sectors, however, warn that over-reliance on provisional mechanisms risks repeating errors from under-evidenced COVID-era authorizations, advocating meta-level safeguards like enhanced pharmacovigilance to inform adaptive regulation.^[165] These debates underscore a broader causal tension: while stringent hurdles demonstrably avert some harms, empirical lags in access may amplify morbidity from treatable conditions, prompting calls for quantitative risk-benefit modeling in policy design.

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Oct 8, 2024 · The Federal Court of Australia has ordered Medtronic Australasia Pty Ltd (Medtronic) to pay an unprecedented $22 million in penalties for ...
[67]
Court action | Therapeutic Goods Administration (TGA)
Jun 20, 2025 · On 23 July 2019, The Federal Court found in the TGA's favour and applied a civil penalty to Peptide Clinics Australia Pty Ltd totalling $10 ...
[68]
Not just hot air: civil penalties for unlawful advertising of therapeutic ...
Nov 22, 2023 · In late October 2023, the Federal Court of Australia awarded civil penalties against both Vapor Kings Pty Ltd and its sole director for ...Missing: prosecutions fines
[69]
Increasing enforcement by the TGA - Market insights - HWLE Lawyers
Jun 28, 2024 · If the use of the goods is likely to result in harm, the maximum penalty is currently imprisonment for 5 years or $1,252,000 or both. If the use ...<|separator|>
[70]
therapeutic goods act 1989 - sect 19b - classic austlii
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both. ... civil penalty provision), by importing into Australia therapeutic goods that ...Missing: fines | Show results with:fines
[71]
TGA threatens illegal semaglutide promoters with jail, $1m fines
Dec 2, 2022 · In addition to imprisonment, the TGA references criminal penalties of up to $888,000 for individuals and $4.44 million for corporations, and ...
[72]
Compliance actions and outcomes
May 27, 2025 · The Act contains criminal offence and civil penalty provisions. Where we believe the Act has been breached, we may issue an infringement notice ...
[73]
International scientific guidelines adopted in Australia
The TGA closely aligns its regulatory approaches to therapeutic products with those of comparable international regulatory counterparts wherever possible.
[74]
Good Clinical Practice (GCP) for clinical trials in Australia
Aug 7, 2025 · The International Conference on Harmonisation (ICH) developed guidance for the conduct of clinical trials, based on the declaration. The ...
[75]
International Medical Device Regulators Forum (IMDRF)
Jun 17, 2025 · The mission of the IMDRF is to strategically accelerate international medical device regulatory harmonisation and convergence.
[76]
Using assessments from comparable overseas regulators for ...
The TGA recognises a range of international assessments and approvals from comparable overseas regulators that sponsors can choose to provide when submitting ...
[77]
Australia | European Medicines Agency (EMA)
Oct 1, 2012 · The European Union (EU) and Australia also have a mutual recognition agreement (MRA) in place on good manufacturing practice (GMP) compliance.
[78]
Mutual Recognition Agreement between Canada and Australia
The MRA allows Canada and Australia to maintain its efficiency and effectiveness of compliance and enforcement efforts, through a mutual recognition of ...
[79]
FDA-Australia Cooperative Agreement regarding Exchange of ...
Jan 30, 2018 · TGA will protect information received from FDA to the extent allowed under Australian law. TGA intends to use information it receives from the ...
[80]
TGA international engagement strategy 2021-2025
Jul 26, 2021 · The TGA plays an important role in facilitating, monitoring and enforcing compliance with the regulatory requirements for therapeutic goods in ...
[81]
[PDF] Therapeutic Goods Administration Performance Report 2023-24
products regulation. Key achievements: • Regulation of vaping products: The TGA took a leading role in the delivery of the. Australian Government's ...
[82]
Safety monitoring and information
Post-market surveillance: We monitor products once they are on the market through adverse event reports, product testing, recalls and safety reviews.
[83]
Reporting of medical device adverse events by healthcare facilities
Aug 26, 2025 · In March 2023, changes were made to the Therapeutic Goods Act 1989 that introduced mandatory reporting of medical device related adverse events ...
[84]
[PDF] Procedure for recalls, product alerts and product corrections (PRAC)
Mar 5, 2025 · Last updated: 5 March 2025 Page 2 The new Procedure for Recalls, Product Alerts and Product Corrections (PRAC), took effect on 5 March 2025.
[85]
Pharmacovigilance in Australia: how do adverse event reports from ...
The Therapeutic Goods Administration analyses adverse event reporting data and uses signal detection methods to identify and evaluate emerging safety signals, ...
[86]
[PDF] health-products-regulation-group-regulatory-science-strategy-2020 ...
New technologies such as gene therapies, other cell and tissue therapies, 3D-printing, and software as a medical device are transforming the way Australians ...
[87]
[PDF] Real World Evidence – Regulatory considerations for Medical Devices
Apr 26, 2024 · The TGA routinely monitors sources of RWE for emergence of important safety signals and may initiate an investigation to determine if there ...
[88]
[PDF] Real world evidence and patient reported outcomes in the ...
Nov 24, 2021 · The TGA will focus on the adoption of regulatory specific guidance to clarify data requirements and encourage the appropriate inclusion of RWE ...
[89]
Fast track approval pathways | Therapeutic Goods Administration ...
Mar 16, 2023 · There are three pathways the TGA can use to assess a prescription medicine: the standard pathway, the priority review pathway and the provisional approval ...Missing: adaptive | Show results with:adaptive
[90]
[PDF] Cell, Gene and Tissue Regulatory Framework in Australia
Therapies which involve ex vivo manipulation of genetic material are classified as gene modified cell therapies. The TGA's current working definition is ...
[91]
[PDF] International Engagement Strategy 2021-2025
Reduced regulatory burden on industry, a fit for purpose regulatory system that is responsive to the latest regulatory science developments and enhanced global ...
[92]
Members & Observers - ICH
This list provides the official names of the Members and Observers used by the ICH Association. Only these names shall be used in ICH when referring to these ...
[93]
ICH Guideline for Good Clinical Practice
Jun 25, 2018 · The Guideline for Good Clinical Practice is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials.
[94]
Head of Australia’s therapeutic goods regulator appointed Chair of international regulatory coalition
### Summary of TGA Head's Appointment as ICMRA Chair
[95]
Project Orbis | Therapeutic Goods Administration (TGA)
Oct 25, 2023 · Project Orbis provides a framework for the collaborative review of promising new cancer treatments among international regulatory partners.
[96]
Project Orbis - FDA
Jul 8, 2025 · Project Orbis is a framework for concurrent submission and review of oncology products among international partners, initiated by the FDA.
[97]
Australia-Canada-Singapore-Switzerland-United Kingdom (Access ...
The TGA is a member of the Access Consortium along with Health Canada ... The International Council for Harmonisation of Technical Requirements for ...
[98]
International agreements and arrangements for GMP clearance
May 21, 2025 · The TGA has various international agreements and arrangements with other countries and regulatory authorities. Some of these allow us to rely on each other's ...
[99]
International engagements | Therapeutic Goods Administration (TGA)
We maintain strong working relationships with international agencies and overseas regulators to help protect public health in Australia.
[100]
New data: Deadly 591-day delay for new medicines | PCFA
Aug 19, 2024 · New research revealing an average 'patient access gap' of 591 days, and up to three years for the listing of some life-saving drugs.
[101]
The TGA's approach to delays in medical device conformity ...
Jun 28, 2023 · Our approach to delays in overseas and Australian conformity assessment recertifications due to the COVID-19 pandemic and the implementation of the EU MDR/IVDR.
[102]
Regulatory overreach - How not to fear (it) - Admin Law Training
May 14, 2025 · Regulators need to stay within the legal framework to avoid regulatory overreach. Overreach can at times lead to actionable economic loss.Missing: criticism | Show results with:criticism
[103]
A small injection of strictness: The TGA's clampdown on cosmetic ...
May 12, 2024 · The updates make it abundantly clear that all direct or indirect advertising of prescription-only medicines is prohibited in Australia.
[104]
TGA enforcement actions rise as Court orders the biggest ... - Lexology
Nov 4, 2024 · Medtronic Australasia Pty Ltd has been ordered to pay a civil penalty of $22 million for supplying its Infuse Bone Graft Kit while it was not included on the ...
[105]
Pan Pharmaceuticals Limited: Regulatory action & product recall ...
Apr 28, 2003 · In 2003, the TGA recalled Pan Pharmaceuticals' products due to serious safety and manufacturing issues.
[106]
Complementary medicines industry in crisis after recall of 1546 ... - NIH
The audit was begun in January after 87 people reported reactions to a travel sickness tablet manufactured by Pan. Nineteen people were hospitalised, the ...Missing: TGA | Show results with:TGA
[107]
Bitter pill for natural therapies industry - AFR
May 5, 2003 · The Pan Pharmaceuticals scandal is a disaster for the $2.5 billion alternative medicine market. It is also not great news for the retail and ...
[108]
Pan founder wins $55m from taxpayers - ABC News
Aug 13, 2008 · The company was fined $3 million after pleading guilty to inflicting grievous bodily harm and manufacturing counterfeit pharmaceuticals. Mr ...Missing: scandal | Show results with:scandal
[109]
(PDF) The effects of an apparent breach of therapeutic regulations ...
Jul 18, 2016 · Pan Pharmaceuticals was suspended (Australian Government 2003a). counter product, most of the recalled products were complementary, listed ...Missing: scandal | Show results with:scandal
[110]
The Implant Files reveal TGA failures in medical device trial
Nov 25, 2018 · The veteran can barely move his left arm after an experimental prosthesis that was made in the United States but never approved there for use, failed.
[111]
Australia sunscreen scandal grows as more products pulled ... - BBC
Oct 1, 2025 · An investigation by the medicines regulator has now warned about 20 more sunscreens from other brands, which share the same base formula, and ...
[112]
Base formulation may be linked to 21 sunscreens falling short of ...
Sep 30, 2025 · The TGA published the list of sunscreens as part of an investigation it launched in June after the consumer advocacy group Choice released its ...
[113]
Multiple sunscreens recall - Lower than claimed SPF levels
Sep 26, 2025 · The TGA published information on 22 August 2025 about a recall of Ultra Violette Lean Screen due to inconsistency in the SPF level shown in ...Missing: scandals | Show results with:scandals
[114]
Australia recalls major sunscreen brands after tests reveal false SPF ...
Oct 11, 2025 · Australians face a sunscreen crisis as a consumer watchdog revealed many popular brands failed SPF claims. This led to product recalls and a TGA ...
[115]
https://www.news.com.au/lifestyle/beauty/face-body/tga-recalls-two-more-australian-sunscreens-over-suspect-spf-claims/news-story/a76b0a110950d8808deada75aa0eafdf
[116]
Govt settles Pan lawsuit for $67.5m - ABC News
Mar 24, 2011 · Customers of Pan Pharmaceuticals have been awarded $67.5 million in compensation. That comes on top of a $55 million payout to Pan's founder Jim Salim in 2008.Missing: scandal | Show results with:scandal
[117]
https://www.sbs.com.au/news/article/more-sunscreens-have-been-recalled-is-yours-among-them/kf8cxj1sd
[118]
COVID-19 vaccines regulatory status
Jul 24, 2025 · To make the provisional pathway work, the TGA has agreed to accept rolling data for COVID-19 vaccines. It's only after all the safety, efficacy, ...
[119]
Early approval of COVID-19 vaccines: Pros and cons - PMC - NIH
This perspective provides an overview of future directions and challenges in advancing promising vaccine platforms to widespread therapeutic use. KEYWORDS: ...
[120]
Surveillance of adverse events following immunisation in Australia ...
Jun 24, 2024 · There were 111,348 AEFI reports for COVID-19 vaccines administered in 2021, an annual AEFI reporting rate of 271.4 per 100,000 doses of COVID-19 ...
[121]
Vaxzevria (AstraZeneca) vaccine and thrombosis with ...
Jun 18, 2025 · There was a link between the AstraZeneca vaccine and a rare but serious side effect called thrombosis with thrombocytopenia syndrome (TTS).Missing: acknowledgment timeline
[122]
COVID-19 vaccine safety report - 15-12-2022
Dec 15, 2022 · To 11 December 2022, the TGA has received 706 reports which have been assessed as likely to be myocarditis from about 44.4 million doses of ...Missing: acknowledgment | Show results with:acknowledgment
[123]
The inconvenient patients Australia's COVID-19 response left behind
Nov 15, 2024 · Australia has a safety system in place for collecting and monitoring reports from doctors of adverse events after a vaccine. The government ...
[124]
Ivermectin: Australian regulator bans drug as Covid treatment after ...
Sep 10, 2021 · Australia's drug regulator has banned medical practitioners from prescribing the anti-parasitic drug ivermectin for “off-label” uses, such as for treating ...
[125]
New restrictions on prescribing ivermectin for COVID-19
Sep 10, 2021 · General practitioners are now only able to prescribe ivermectin for TGA-approved conditions (indications) - scabies and certain parasitic infections.Missing: hydroxychloroquine | Show results with:hydroxychloroquine
[126]
Ivermectin: A Controversial Focal Point during the COVID-19 ...
The controversy over its use for the treatment of COVID-19 is demonstrated by this report that considers the proposal unfeasible because the therapeutic ...
[127]
Removal of prescribing restrictions on ivermectin
May 3, 2023 · From 1 June 2023, prescribing of oral ivermectin for 'off-label' uses will no longer be limited to specialists such as dermatologists, gastroenterologists and ...Missing: hydroxychloroquine | Show results with:hydroxychloroquine
[128]
Former Liberal MP Craig Kelly claims the TGA has 'surrendered' on ...
May 11, 2023 · United Australia Party national director Craig Kelly says the TGA "surrendered" on antiparasitic drug ivermectin with its decision to allow ...
[129]
Changes proposed to TGA fees and charges - AusBiotech
Feb 3, 2022 · Working through a 96 percent cost recoverable model, the TGA reviews its fees and charges annually to ensure they're set at the appropriate ...Missing: funding | Show results with:funding
[130]
Therapeutic Goods Administration rejects claims it is 'too close' to ...
Nov 8, 2017 · Health experts say accepting fees from industry is unacceptable following the transvaginal mesh scandal.
[131]
Professor John Skerritt appointed to Medicines Australia Board
4 December 2023: Professor John Skerritt has been appointed to the Medicines Australia Board as an Independent Selected Director. “I am delighted to ...
[132]
Drug regulators - the revolving door keeps revolving
Jan 22, 2024 · Former TGA boss appointed to the board of Medicines Australia, hoping to advance "mRNA technology framework" in Australia.
[133]
Managing conflicts of interest and confidentiality obligations on ...
Aug 8, 2011 · Guidance on declaring and managing conflicts of interest and confidentiality obligations for TGA advisory committee members.Missing: revolving door
[134]
[PDF] Review to improve the transparency of the Therapeutic Goods ...
Jun 20, 2011 · Review to improve transparency of the Therapeutic Goods Administration (TGA). The Parliamentary Secretary for Health and Ageing, the Hon ...Missing: controversies peer-
[135]
Problems with TGA transparency, says Australian study
Mar 5, 2012 · Another issue the research highlights is the lack of transparency about what class of devices are recalled by the TGA. "Current product recalls ...
[136]
TGA criticised over lack of safety warnings - RACGP
May 6, 2019 · Questions have been raised over the way Australia's therapeutic regulator is informing doctors and patients about potentially dangerous drugs.
[137]
The Australian obesity epidemic and the regulation of ...
A search of the TGA advertising complaints database found 'no result' for 84% of the 140 cases submitted. Despite the TGA delisting three products and ...
[138]
[PDF] Regulatory update from Australia
Sep 26, 2023 · The three strategies in the Action Plan are: 1. Pre-market medical device reforms - improve how new devices get on the market.<|separator|>
[139]
TGA medical device regulation changes - Pharmavibes
Jun 24, 2024 · From 1 July 2024, mandatory application audits will be limited to high-risk medical devices and in vitro diagnostic (IVD) medical devices.
[140]
Medical devices reforms | Therapeutic Goods Administration (TGA)
Apr 15, 2024 · The Medical Devices Reforms aim to enhance the safety, performance, and quality of medical devices in Australia and focus on patient safety.Missing: growth | Show results with:growth
[141]
TGA seeks sector views on proposed changes to Essential ...
Aug 22, 2024 · The Therapeutic Goods Administration (TGA) is seeking industry feedback on proposed changes to the Australian Essential Principles for Safety and Performance ...
[142]
Australia's SaMD Regulatory Transition - Asia Actual
Apr 16, 2024 · Beginning on November 1st, 2024, Australia's TGA will fully implement new rules surrounding software as a medical device (SaMD).
[143]
TGA publishes consultation findings: AI and medical devices
Aug 6, 2025 · The TGA's review confirms current medical device regulations are broadly suitable for AI, but targeted reforms are needed to address key gaps.
[144]
Australia Prepares Regulatory Shift for AI Medical Devices
Aug 7, 2025 · The TGA is considering updates to core definitions like “manufacturer” and “sponsor”, to reflect how AI software is created and maintained.
[145]
It's alive — and growing! Updates from the TGA's 2025 AI review
Aug 5, 2025 · The TGA's 2025 review signals a proactive and consultative approach to regulating medical device software and AI. While the core framework ...
[146]
Therapeutic Goods Legislation Amendment effective from 1 October ...
Oct 1, 2025 · Therapeutic Goods Legislation Amendment effective from 1 October 2025. This Legislation Amendment makes changes to the way testing of goods is ...Missing: timeline | Show results with:timeline
[147]
[PDF] Interim Evaluation #2 of the Prescribed List Reforms
Sep 19, 2025 · Industry stakeholders noted that it is too early to fully assess the impact of the reforms on clinician choice; however, they raised concern ...
[148]
[PDF] Inquiry into approval processes for new drugs and novel medical ...
The TGA is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose.Missing: crises | Show results with:crises
[149]
[PDF] Regulatory update from TGA Australia
Oct 13, 2024 · o Any legislative change will be subject to Government decision. Page 4. Vaping reforms – special arrangements for devices. From 1 July 2024.
[150]
Artificial Intelligence (AI) and medical device software
Sep 4, 2025 · We regulate Artificial Intelligence (AI) as a medical device when it is used for diagnosis, prevention, monitoring, prediction, prognosis, treatment, or ...When AI is considered a... · How AI medical devices are... · Generative AI regulation
[151]
Understanding regulation of software-based medical devices
Find out how TGA regulates software and artificial intelligence (AI) based medical devices. Published. 21 June 2022. Last updated. 29 August 2025. Listen; Print
[152]
TGA AI Review: Outcomes report published
Jul 30, 2025 · We have published our Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI) report.
[153]
TGA AI & Software Regulations: Impact on Medical Devices - RegDesk
Sep 19, 2025 · Discover how the TGA regulates AI in medical devices, key compliance steps, and evidence requirements for MedTech in Australia.
[154]
[PDF] Clarifying and strengthening the regulation of Medical Device ...
The final aspect is the powers TGA has to compel sponsors and manufacturers to engage with post- market review, monitoring and recall activities. We. Page 30 ...Missing: explainability | Show results with:explainability
[155]
Australia TGA Targets AI and Software-Based Tools in 2025 ...
Sep 10, 2025 · TGA's 2025 compliance update covers AI and software-based medical devices under the Therapeutic Goods Act 1989. Tools like AI scribes may ...
[156]
Global Harmonization of Artificial Intelligence-Enabled Software as a ...
The growing incorporation of artificial intelligence (AI) into medical device software offers substantial prospects and regulatory hurdles.<|separator|>
[157]
Australian access to FDA-approved breakthrough therapy ...
Aug 21, 2024 · There was no difference in time from FDA approval to TGA approval for cancer and non-cancer BTDs with median (IQR) time calculated as 299 days ( ...Data Collection · Table 1. Tga And Pbs... · Approval Timelines<|separator|>
[158]
Does Regulatory and Reimbursement Parallel Processing Provide ...
Dec 16, 2024 · This is the first study that describes the clinical evidence submitted under the TGA-PBAC parallel process for cancer drug submissions in ...
[159]
Independent review of TGA provides sensible solutions to ...
The Review examined the TGA's regulatory framework and processes with a view to identifying areas of unnecessary red tape and opportunities to enhance and ...
[160]
The hazards of rapid approval of new drugs - Australian Prescriber
Feb 1, 2016 · Prescribers should be aware of some of the examples where inadequate information at the time of rapid registration has been followed by ...
[161]
Review of Recent Regulatory Amendments in Australia
Oct 15, 2024 · The TGA has enacted several reforms to advance regulatory harmonization or reliance. Manufacturers are able to leverage existing conformity assessment evidence.
[162]
Australia Expands Reference Market Inclusion for Medical Devices
Oct 29, 2024 · In this amendment, the TGA will now accept an FDA 510(k) substantial equivalence notification accompanied by a Medical Device Single Audit ...
[163]
[PDF] Consultation: Expedited pathways for prescription medicines
The Therapeutic Goods Administration (TGA) is developing two expedited pathways for the registration of novel prescription medicines that address unmet ...
[164]
[PDF] Australian Government Response to the Review of Medicines and ...
It identifies ways to improve access to therapeutic goods for consumers and remove unnecessary red tape for industry whilst maintaining the safety of ...
[165]
[PDF] Therapeutic Goods Administration Performance Report - 2022-23
Unapproved medicine approvals have significantly increased by 9.3% for Special Access. Scheme B (SAS B) and 14% for Authorised Prescriber (AP) applications, ...