The primary legislation that governs the importation, exportation, manufacture and supply of therapeutic goods in Australia – including pharmaceuticals and medical devices – is the Therapeutic Goods Act 1989 (Cth). The Therapeutic Goods Act establishes Australia’s national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods, and provides the framework for the states and territories to adopt a uniform approach to the safe handling of poisons (including medicines).

The Therapeutic Goods Act is supported by a number of regulations, including the following two key sets of subordinate regulations:

• the Therapeutic Goods Regulations 1990, which provide detailed rules around manufacturing, supply, advertising, labelling and post-market surveillance of medicines; and
• the Therapeutic Goods (Medical Devices) Regulations 2002, which set out the requirements for registration, classification and conformity assessment of medical devices specifically.

The Therapeutic Goods Administration (TGA) is Australia’s principal regulatory authority for therapeutic goods. The TGA’s remit includes all aspects of the supply, importation, exportation, manufacturing and advertising of therapeutic goods, while also maintaining the Australian Register of Therapeutic Goods (ARTG). A therapeutic good cannot be supplied in Australia unless it is listed, registered or included on the ARTG (as applicable).

The TGA is not an independent statutory authority and operates as a division of the Department of Health, Disability and Ageing, in its Health Products Regulation Group (HPRG). At a practical level the TGA is can be described as “semi-autonomous”, with broad day-to-day operational independence, its own organisational identity and its own head (who also holds the title of Deputy Secretary of the HPRG).

State and territory laws govern the storage, handling, retail and wholesale of poisons, including medicines.

In addition, the National Health Act 1953 (Cth) and its delegated legislation establish the Pharmaceutical Benefits Scheme (PBS), which is Australia’s Commonwealth (federal) Government scheme to subsidise the cost of drugs and medicinal products (primarily prescription medicines). There is also a Prescribed List (formerly known as the Prostheses List), which sets a minimum list and associated benefit for certain medical device and human tissue products that must be covered by health insurers in respect of private health insurance.

Three-Tiered System

Australia’s therapeutic goods regime has a three-tiered system for challenging regulatory decisions, the availability of which will depend on the decision and decision-maker in question.

Internal merits review by the Minister

The Therapeutic Goods Act provides (in Section 60) that certain “initial decisions” made by the Secretary of the Department of Health, Disability and Ageing or their delegate may be eligible for reconsideration, which is a form of merits review. A person whose interests are affected by an initial decision of the TGA may request that the Minister review the decision within 90 calendar days. The Minister may confirm or revoke the initial decision, and may make a decision in substitution for the initial decision. The Minister is not limited to checking whether the original decision-maker made an error in the making of the decision.

External merits review (ART)

The Minister’s decision on reconsideration becomes a “reviewable decision”, and a person whose interests are affected by the decision may apply to the Australian Review Tribunal (ART) (which replaced the AAT on 14 October 2024) for review of that decision. The ART considers all evidence before it and seeks to make the “correct or preferable decision”. An application to the ART must be filed within 28 days of being notified of the Minister’s decision (and reasons for that decision).

Judicial review (Federal Court)

A person aggrieved by certain administrative decisions made by a public authority may seek judicial review under the Administrative Decisions (Judicial Review) Act 1977 (the “ADJR Act”) or under Section 39B of the Judiciary Act 1903. Judicial review is different to merits review, and is an examination of whether decision was made lawfully – that is, whether the process by which the decision was made was lawful, fair and reasonable, rather than whether the correct decision was in fact made. 

Judicial review procedures (in contrast to the merits review procedures) may be available in respect of government decision-making by any level of government, unless the decisions are expressly excluded from such review. Judicial review is often considered in respect of Ministerial decisions relating to the Pharmaceutical Benefits Scheme, or steps preparatory to the making of such decisions (eg, recommendations by the Pharmaceutical Benefits Advisory Committee).

Food products are regulated by reference to the Food Standards Code, which are given legal status by application laws in each state and territory. The state Food Authorities are the regulatory bodies for those standards.

Australia uses a risk-based tiered system for regulating therapeutic goods. The level of risk associated with a particular category of product will dictate the application pathway for inclusion on the ARTG, as well as what evidence is required to be held or provided to the TGA to achieve a listing. The higher the classification, the more rigorous the pre-market assessment will be.

Low-risk medicines (most vitamins and supplements) are simply listed on the ARTG based on sponsor self-certification, while higher-risk medicines (prescription drugs, over-the-counter (OTC) medicines) may only be registered after a full TGA evaluation of safety, quality and efficacy. In addition, substances (including in certain forms or concentrations) may be “scheduled” by being included on the Poisons Standard. The Poisons Standard is a legislative instrument that classifies substances (again by risk) into “Schedules”, including Schedule 2 (Pharmacy Only), Schedule 3 (Pharmacist Only), Schedule 4 (Prescription Only) and Schedule 8 (Controlled Substances). Scheduling also impacts storage and handling requirements (governed by state and territory legislation).

Unscheduled (or General Sale) Medicines

Unscheduled medicines have been determined to be suitable for supply without supervision by a qualified healthcare professional and are available for general sale (such as in supermarkets). Sometimes, these medicines will be a smaller pack size or lower dosage than other scheduled medicines.

Medical devices are subject to a separate classification framework with risk tiers ranging from Class I (low-risk items such as bandages, largely self-certified) through to Class III (high-risk items such as heart valves or other implantable devices, requiring more detailed assessment by the TGA). A parallel four-class system assesses in vitro diagnostic devices.

Clinical trials of unapproved therapeutic goods in Australia are regulated by the TGA under the Therapeutic Goods Act 1989 (Cth) and associated regulations, including the Therapeutic Goods Regulations 1990 (Cth) and the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth).

More specifically, unapproved therapeutic goods (including pharmaceuticals and medical devices) are exempt from the requirement to be listed, registered or included on the ARTG where those goods are being supplied for use in a clinical trial solely for experimental purposes in humans and where such supply is subject to oversight by the TGA via either the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) pathway. Unapproved goods also include therapeutic goods which are included in the ARTG but which will be used in a manner not covered by the existing ARTG entry during the clinical trial.

The regulatory framework applies to medicines, biologicals and medical devices, and is supported by ethical and governance requirements at the institutional level. Clinical trials must comply with:

• the National Statement on Ethical Conduct in Human Research (the “National Statement”) issued by the National Health and Medical Research Council;
• relevant Good Clinical Practice (GCP) guidelines, including the International Council for Harmonisation (ICH) GCP Guideline for medicines and biologicals; and
• principles based on the Declaration of Helsinki.

Clinical trials must be conducted in accordance with a Protocol approved by a Human Research Ethics Committee (HREC), which will also be responsible for monitoring the conduct of the trial at each study site. A clinical sponsor, which must be an Australian entity, will take on the obligations of running the trial, including making any notification or application to the TGA under the CTN and CTA pathways. Clinical trials that do not involve the use or supply of unapproved products do not need to follow the CTN or CTA pathways but will still require HREC supervision.

State and territory laws, and institution-based rules, should also be taken into account. Importantly, together with the industry body for innovative medicines, Medicines Australia, the National Clinical Trial Agreement (NaCTA) Panel (comprised of representatives from all states and territories) has developed five Clinical Trial Research Agreements that are available for use by any sponsor and/or institution for specific types of clinical trials. Certain institutions (eg, public hospitals) conducting clinical trials will insist on using these Agreements without amendment.

The clinical trial sponsor must determine whether a clinical trial will proceed under the CTN or CTA pathway, based on the risk profile of the investigational product. The choice of pathway must also be confirmed by the HREC.

The main difference between the pathways is the level of TGA review before the clinical trial commences. The CTA pathway is typically used for higher-risk or novel treatments such as gene therapy, where there is no or limited knowledge of safety associated with the product. The CTN pathway can be used for all other studies, but will usually be appropriate where there is already some pre-clinical data supporting the safety of the device in humans. Studies involving Class 4 biologicals must use the CTA pathway unless evidence from previous clinical use supports the use of the biological or a national regulatory body with comparable regulatory requirements has approved a clinical trial for an equivalent indication.

The TGA has recently been undertaking a review of the CTA pathway, including in relation to the focus for review of the TGA compared to the HREC. This review is ongoing.

CTN Pathway

The CTN scheme is a notification scheme. The TGA does not review or evaluate any data relating to the clinical trial.

Under the CTN pathway:

• the clinical trial sponsor obtains HREC approval and site governance authorisations;
• the clinical trial sponsor submits an online notification to the TGA and pays the applicable fee;
• any variations to the information submitted as part of the CTN form during the clinical trial must also be notified to the TGA; and
• the clinical trial sponsor should submit further notification to the TGA once the clinical trial activity relating to the supply of unapproved therapeutic goods is complete.

CTA Pathway

The CTA scheme is an approval scheme. The TGA will review manufacturing, safety and quality data, including any relevant pre-clinical or early clinical data that may be available, even if limited, to conduct a risk-benefit analysis that will inform their decision about whether to approve the trial.

Under the CTA pathway:

• the clinical trial sponsor submits an application to the TGA for evaluation and approval of the investigational product’s use in the trial, and pays the applicable fee;
• once TGA approval is granted, the clinical trial sponsor must still obtain HREC approval (which will focus on scientific and ethical issues relating to the clinical trial protocol) and site governance authorisations before commencing the trial;
• any significant changes to the manufacturing and quality and safety data reviewed and approved by the TGA, or any other aspect of the trial provided to the TGA with the CTA application, must be given to the TGA and may also require TGA approval; and
• clinical trial sponsors should also notify the TGA of clinical trial completion after the trial has been completed at all study sites.

While the legislation does not expressly require the registration of clinical trials in Australia, the National Statement mandates that researchers must register any research project that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes on a publicly accessible registry before participant recruitment begins.

When registered, certain information about each clinical trial, including results after trial completion, will be made available to the public. Clinical trial registries include the Australian New Zealand Clinical Trials Registry (ANZCTR), the US ClinicalTrials.gov or the World Health Organization (WHO) International Clinical Trials Registry Platform.

The use of digital technology – including online recruitment, e-consent, electronic patient-reported outcomes (ePROs), telehealth and remote monitoring – is generally permitted in clinical trials in Australia. Many clinical trial sponsors utilise these tools to recruit participants, conduct virtual trials, manage data and monitor outcomes. In using these tools, clinical trial sponsors must comply with:

• good clinical practice principles;
• the Privacy Act 1988 (Cth) (including the Australian Privacy Principles (APPs) set out therein) and any relevant state/territory health privacy legislation;
• the National Statement;
• HREC approvals; and
• site governance requirements.

Given that health information is classified as sensitive information, it is subject to higher protections.

All recruitment materials and processes, including online materials, require approval from the relevant HREC. Sponsors must provide clear collection notices and obtain express consent where necessary.

Clinical trial sponsors must also ensure that they implement proportionate security measures to protect data and ensure that any third-party service providers comply with Australian privacy legislation. Contracts with service providers should address key aspects such as data processing, security and audit rights.

Clinical trial datasets commonly contain personal information and often sensitive information (including health and genetic information). As a result, handling and sharing of trial data must align with the Privacy Act 1988 (Cth) (including the Australian Privacy Principles found in the Privacy Act), and any applicable state and territory health privacy legislation.

For Australian law purposes, personal information is any information or an opinion about an identified individual or an individual who is reasonably identifiable. The question of whether an individual is reasonably identifiable from the information or opinion in question depends on context and the circumstances in which the information is held. For this reason, anonymised or pseudonymised trial data might still be considered personal information and therefore subject to the requirements of Australia’s privacy laws.

Use and disclosure should be limited to the research purposes for which the data was collected unless a relevant exception applies or fresh consent is obtained. Research-specific allowances may be available under approved guidelines where consent is impracticable and public interest tests are met, subject to HREC approval.

Disclosures to CROs, service providers and affiliates must be documented and controlled. Cross-border disclosures require reasonable steps to ensure that overseas recipients protect personal information consistently with the APPs and engage accountability for offshore disclosures. Appropriate contractual, technical and organisational measures should be in place, and de-identified datasets should be used where feasible.

Creating a database that contains personal or sensitive information will be required to meet minimum requirements set out in the Privacy Act. Patient consent forms supporting the creation and use of such a database will be important to what additional requirements will be needed. The Australian Privacy Principles impose a range of obligations, including to:

• maintain a clear, up-to-date privacy policy and privacy management plan, assign accountability, and embed privacy by design;
• collect only what is reasonably necessary for the research and related operational purposes;
• implement proportionate technical and organisational security controls, vendor due diligence and access management; and
• establish retention schedules and destroy or de-identify personal information when no longer required.

Classification in Australia turns on the principal intended action of the product. If a product works by pharmacological, immunological or metabolic means, it is a medicine; if it works by physical means, it is a medical device. Biologicals (products derived from human cells/tissues) are classified by what they are made from, not how they work.

The following key points are relevant for the assessment process:

• classification is the responsibility of the medicine or device manufacturer – however, the sponsor will be required to make the application and to make certain certifications to the TGA;
• the TGA provides online decision tools to guide sponsors through the process, and sponsors can also consult the TGA directly for novel or ambiguous products; and
• for medical devices, the manufacturer assigns the intended purpose for a device and will also determine the risk class (Class I–III, or Class 1–4 for in vitro diagnostic devices), having regard to whether the device is powered and the body system involved.

Often, products do not neatly correspond to one category, and will depend on therapeutic claims made and the scientific evidence for the how the product works. Boundary or combination products will be classified according to their principal therapeutic effect. A number of legislative instruments also declare or determine certain products to be therapeutic goods, or to be excluded from the application of the therapeutic goods regime.

In Australia, biological medicines (eg, monoclonal antibodies, vaccines, gene therapies) follow the same registration pathway as other prescription medicines on the ARTG. There is no separate biologics licence in Australia. At a practical level, manufacturing and quality (CMC) data for biologicals may face heightened scrutiny as biologicals are produced from living systems and are generally more variable than conventional chemical drugs.

In Australia, ARTG entries for medicines and medical devices do not expire, and an entry remains valid indefinitely, provided the sponsor continues to meet its ongoing obligations (namely, payment of annual charges where applicable) and the product is not otherwise cancelled or suspended from the ARTG. Provisional registration for certain therapeutics will expire after two years (extendable up to six years), if the sponsor has not submitted confirmatory clinical data during that period.

The TGA:

• can suspend marketing authorisation/ARTG registration on grounds including safety or quality concerns, non-compliance with conditions, failure to pay annual charges, or the provision of false or misleading information;
• can suspend authorisation as an interim measure while concerns are investigated; and
• cannot suspend marketing authorisation due to “failure to market”, unlike in the EU – however, the TGA discourages sponsors from leaving their products on the ARTG where they have determined that no further supplies of the product will occur in Australia.

To obtain a marketing authorisation for a registered medicine, a sponsor must submit an application via the TGA Business Services (TBS) portal, supported by a dossier in Common Technical Document (CTD) format. The TGA evaluates the medicine within maximum statutory timeframes, being up to 255 working days, reduced to 175 working days where the medicine is already approved by a comparable overseas regulator, and further reduced to 120 working days where manufacturing is acceptable and only labelling/product information and risk management remain outstanding. The legislation also permits certain “clock stop” periods where the TGA has made a request for information.

Once a medicine is registered on the ARTG, no change to the medicine as approved by the TGA can be made without TGA notification or approval – depending on the variation in question. Those changes that will require evaluation of clinical or bioequivalence data will be more significant. Most changes to a sponsor will simply require notification to the TGA.

Listed medicines are not individually evaluated by the TGA for quality, safety or efficacy before they can be supplied in the marketplace. A sponsor must certify that the listed medicine meets applicable requirements and that all ingredients are found on the Therapeutic Goods (Permissible Ingredients) Determination (No 1) 2026 (Cth).

A new listing or registration on the ARTG (and therefore a new application) must be sought for any medicine that is “separate and distinct” from other therapeutic goods (including any current listings/registrations). This includes where the formulation or composition of the goods is different, the medicines have different dosage forms and strengths, and the product has a different name.

For medical devices, sponsors must demonstrate compliance with the Essential Principles and apply appropriate conformity assessment procedures. Independent certification of the manufacturer’s conformity assessment procedures is required for all classifications except for Class I non-sterile, non-measuring devices and Class 1 IVD devices (which can be self-certified by the manufacturer providing a Declaration of Conformity). Where devices are manufactured outside Australia, sponsors may be able to rely on certification from EU Notified Bodies or approvals from comparable overseas regulators (US FDA, Health Canada, Japan PMDA, Singapore HSA), as set out in the Therapeutic Goods (Medical Devices – Information that Must Accompany Application for Inclusion) Determination 2018 (Cth).

Where TGA conformity assessment certification is required for a new application, this process must be completed within a statutory timeframe of up to 255 working days. Otherwise, applications for ARTG inclusion must be approved or selected for audit within a statutory timeframe of 20 business days. As with medicine applications, the legislation also permits certain “clock stop” periods where the TGA has made a request for information.

For medical devices, a single ARTG entry may cover more than one device (and instead covers a “kind of medical device”), provided that they have the same sponsor, manufacturer, device nomenclature system code, medical device classification and, for certain higher risk products (Class 4 IVDs, Class III devices and IVD companion diagnostics), the same unique product identifier.

Transfer of a sponsorship for a medicine or medical device is permitted. The legislation provides that the change of sponsor occurs automatically upon the happening of certain events – however, in practice, the process requires:

• notification to the TGA of the change in sponsor;
• updating the ARTG to reflect the new sponsor’s details; and
• the new sponsor applying for a variation to update the product information and labelling with the new sponsor details.

There are four main pathways for accessing therapeutic goods that do not have applicable market authorisation (ie, that are not on the ARTG) in Australia.

Special Access Scheme

This allows registered health practitioners to access unapproved medicines, devices or biologicals for individual patients on a case-by-case basis. There are three subcategories:

• immediate access for seriously ill patients (category A);
• TGA pre-approval (category B); and
• immediate access for products with an established history of use (category C).

Authorised Prescriber Scheme

This allows medical practitioners to prescribe a specified unapproved good to a class of patients with the same condition, without needing individual approvals, subject to Human Research Ethics Committee approval or specialist college endorsement.

Clinical Trials

These allow unapproved goods to be supplied to patients enrolled in an approved clinical trial conducted under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) scheme, provided that specified requirements for the supervision and conduct of the clinical trial can be met.

Personal Importation

Individuals may import a limited supply of an unapproved medicine for their own personal use, subject to conditions.

Compassionate use programmes typically apply to medicines (or devices) after they have received market authorisation (registered on the ARTG) but before (or separate from) reimbursement on the PBS. It is an offence to advertise unapproved therapeutic goods to the public.

The Therapeutic Goods Act 1989 (Cth), Therapeutic Goods Regulations 1990 (Cth) and Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) impose standard conditions on the person in relation to whom a medicine is registered or listed, or in relation to whom a medical device is included, on the ARTG. These include obligations relating to post-marketing surveillance, including pharmacovigilance and technovigilance, as well reporting requirements.

Pharmacovigilance (Medicines)

It is a condition on registration or listing that the person in relation to whom a medicine is registered or listed on the ARTG must comply with the record-keeping and reporting requirements set out in the document published by the TGA titled Pharmacovigilance Responsibilities of Medicine Sponsors (as in force from time to time, and given force by the Therapeutic Goods Regulations). Sponsors must report adverse events to the TGA in accordance with those requirements, including reporting serious/unexpected events within 15 calendar days and significant safety issues within 72 hours. Sponsors must also maintain updated risk management plans and adhere to any TGA-imposed post-market conditions (especially if provisionally registered).

Technovigilance (Medical Devices)

It is a condition on inclusion that the person in relation to whom a device is included on the ARTG must give certain information to sponsors and must comply with the record-keeping and reporting requirements set out in the Therapeutic Goods (Medical Devices) Regulations. Sponsors must report adverse events involving their devices to the TGA, including events that led or might have led to death, serious injury or serious deterioration in health. Sponsors must also maintain a post-market surveillance system including systematic review of post-market experience.

Common Obligations (Medicines and Medical Devices)

Sponsors must ensure continued compliance with Good Manufacturing Practice and conformity assessment requirements throughout the product life cycle, pay annual ARTG charges, and ensure that product information, labelling and advertisements are kept up to date and in line with TGA requirements. For both medicines and medical devices, a sponsor must follow the TGA’s procedure for recalls, product alerts and product corrections (PRAC) and – except where immediate action is required – must engage with the TGA and receive its approval before taking in-field action in relation to a recall.

The TGA publishes on its website a database of applications for new medicines or new uses for existing medicines that are currently under evaluation by the TGA. The following will be published on this database:

• information about applications for a “new medicine” containing a new active substance (new chemical entity or new biological entity) not currently approved in Australia;
• applications for a “new combination” where two or more already approved medicines are combined into a single product; and
• applications for a “new indication” or additional therapeutic use for an already approved medicine.

Using this “Prescription Medicine Applications Under Evaluation” database, third parties can review the proposed product trade name, active ingredient(s), the applicant (who will become the sponsor), a summary of the proposed indication and the application type. The database is updated monthly.

Once the TGA has made its decision in relation to an application, the following applies.

• If approved and included in the ARTG, a third party can access the product name, sponsor, active ingredients, ARTG number, and conditions of registration (if any, in addition to the standard conditions imposed by statute) via the publicly accessible ARTG.
• For approved prescription medicines, an Australian Public Assessment Report (AusPAR) that summarises the clinical, non-clinical and quality evaluation, including the basis for the decision, may be published on the TGA’s website. The TGA’s guidance is that AusPARs will typically be published for products containing new chemical and biological entities, biosimilar medicines, major variations and extensions of indications where the TGA decision-maker received independent expert advice, or where the information is considered to be in the interest of the Australian public. An AusPAR may still be published even if an application was rejected.
• The TGA also publishes prescription medicine decision summaries (AusPMDSs), providing a brief overview the TGA’s assessment and decision to approve or not approve a new prescription medicine.

Information about applications for medical devices is not published.

Section 61 of the Therapeutic Goods Act prohibits TGA officials from disclosing “protected information”, which broadly includes any information obtained under the Act that is not publicly available, except in specified circumstances (eg, to protect public health, for law enforcement, or with the sponsor’s consent). Furthermore, Australian privacy legislation would ordinarily prohibit the publication of information relating to individuals (especially health or other sensitive information), unless they have expressly given consent.

The TGA offers several accelerated pathways for therapeutic goods.

Priority Review

This is available for medicines addressing serious conditions with unmet clinical need. It reduces the evaluation timeframe to 150 working days (versus the standard 255-working-day timeframe).

Provisional Registration

This allows time-limited approval (up to two years, which may be extended to six) based on preliminary clinical data where the medicine shows promise for treating a serious condition. The sponsor must submit confirmatory data during the provisional period.

Provisional Determination

This is the equivalent fast-track pathway to the provisional registration pathway, but for biologicals (human cell/tissue products).

Comparable Overseas Regulator (COR) Pathways

Where a medicine is already approved by a recognised regulator (eg, FDA, EMA, Health Canada, MHRA), the TGA can rely on that assessment, reducing the evaluation to 175 working days. Applications for inclusion of a medical device that rely on assessments completed by overseas regulators will also shorten the time needed by the TGA to make its decision (evidence requirements are identified in the Therapeutic Goods (Medical Devices – Information that Must Accompany Application for Inclusion) Determination 2018 (Cth)).

Orphan Drug Designation

This is for medicines that treat rare diseases (fewer than 2,000 Australians per year). It provides fee waivers rather than a shorter timeline, but can be combined with priority review.       

Australia is an active adopter of regulatory reliance.

The TGA maintains a formal list of Comparable Overseas Regulators (CORs), which currently includes the FDA, EMA, Health Canada, the MHRA, Swissmedic and Singapore HSA. The regulatory reliance regime in Australia operates as follows:

• for medicines, the COR pathway reduces evaluation from 255 to 175 working days, and the TGA can leverage the overseas regulator’s clinical and quality assessments rather than duplicating them entirely; and
• for medical devices, the TGA accepts conformity assessment evidence from COR jurisdictions, which can substantially shorten the ARTG inclusion process.

Australia also participates in the Australia-Canada-Singapore-Switzerland-UK (Access) Consortium, which enables work-sharing arrangements on new medicine evaluations, meaning that multiple regulators assess different components of the same dossier collaboratively.

All manufacturers of therapeutic goods must hold a TGA manufacturing licence if manufacturing in Australia. Manufacturers will be required to comply with Good Manufacturing Practice (GMP) standards, and a licence will be granted following a GMP inspection of the site by the TGA. TGA manufacturing licences are granted for a maximum of five years and must be renewed before expiry. The TGA conducts periodic re-inspections (typically every two to three years) to confirm ongoing GMP compliance.

Overseas manufacturers can obtain GMP clearance or certification. Australia also has mutual recognition agreements with certain regulatory authorities within Europe, the UK, Canada, Singapore and New Zealand that allow mutual recognition of GMP inspection outcomes of medicine manufacturers within their borders. The TGA also has (non-binding) Memorandums of Understanding with Health Canada and Swissmedic and co-operative agreements (written understanding) with the US FDA and the European Directorate for the Quality of Medicines, which facilitate information-sharing.

The TGA can suspend or revoke a manufacturing licence or GMP clearance at any time if it identifies serious non-compliance, which effectively prevents supply of all products manufactured at that site.

Manufacturers of medical devices must operate under a certified quality management system (QMS) conforming to ISO 13485. This is verified through the conformity assessment process rather than a separate manufacturing licence. Sponsors of medical devices are required to hold evidence or have a written agreement with the manufacturer of a medical device that will enable it to obtain (within a legislated timeframe) evidence relating to compliance with essential principles and conformity assessment procedures.

Wholesale of scheduled medicines is regulated primarily at the state and territory level, not by the TGA. Each Australian state or territory has its own legislation that requires wholesalers to hold a licence issued by its health department under local poisons and therapeutic goods legislation.

For example, in New South Wales, wholesale licencing is issued by NSW Health under the Poisons and Therapeutic Goods Act 1966 (NSW) and the Poisons and Therapeutic Goods Regulation 2008 (NSW). An application is lodged with NSW Health and can take up to four weeks to approve. All licences expire on September 30th each year and must be renewed annually by payment of the renewal fee. A wholesaling licence will specify the premises from which the business is licensed to wholesale goods, and the categorisation (by reference to the Schedule on the Poisons Standard) of the poisons or medicines that the business is permitted to wholesale.

While each state or territory governs licence validity and renewal periods, wholesalers must comply with the Australian Code of Good Wholesaling Practice for Medicine in Schedules 2, 3, 4 and 8 (CGWP). The CGWP imposes requirements on storage, stock handling, security, cold chain management, record-keeping and recall procedures.

Australia classifies medicines for supply purposes through the Poisons Standard (SUSMP), which assigns active ingredients to Schedules determining the level of how freely the product can reach consumers.

The relevant categories are as follows.

• Unscheduled: available for general sale, accessible at supermarkets, health food stores and general retail (eg, low-dose vitamins).
• Schedule 2 – Pharmacy Medicine: available from pharmacy shelves without a prescription, though a pharmacist must be available for advice (eg, ibuprofen or paracetamol, depending on the strength and pack size, and where specified conditions are met).
• Schedule 3 – Pharmacist-Only Medicine: available only directly from a pharmacist behind the counter, who must provide advice at point of sale. No prescription required (eg, emergency contraception, salbutamol inhalers).
• Schedule 4 – Prescription-Only Medicine: requires a prescription from an authorised health practitioner and dispensing by a pharmacist (eg, antibiotics, antidepressants, antihypertensives).
• Schedule 8 – Controlled Drug: requires a prescription with additional controls on prescribing, dispensing, storage and record-keeping, with some states requiring prescriber permits (eg, opioids such as morphine and oxycodone, amphetamines).
• Schedule 9 – Prohibited Substance: illegal to produce, possess, sell or use except for approved research, with limited therapeutic exceptions (eg, since July 2023 for MDMA and psilocybin under psychiatric supervision) (ie, most illicit drugs).

The Therapeutic Goods Act 1989 (Cth) is the primary legislation governing both importation and exportation of therapeutic goods. It is supported by the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002.

For controlled substances (narcotics, psychotropics, precursors), additional import/export controls are imposed by the Customs (Prohibited Imports) Regulations 1956 and the Customs (Prohibited Exports) Regulations 1958, which prohibit importation or exportation without a licence and/or permit.

Enforcement of the import regulations are governed by the TGA, in respect of therapeutic goods pursuant to the ARTG. The Australian Border Force (ABF) enforces import/export controls at the point of entry. The Office of Drug Control (ODC) regulates the importation and exportation of controlled substances, and the Department of Agriculture, Fisheries and Forestry administers quarantine and biosecurity controls at the border for products containing materials of biological origin (human, animal, plant or bacterial).

Australian legislation does not use the phrase “importer of record”; however, the regulatory framework for therapeutic goods centres on the role of the sponsor as the relevant importer. The sponsor is the key legal entity responsible for importing, exporting or manufacturing therapeutic goods for supply in Australia, pursuant to Section 3(1) of the Therapeutic Goods Act 1989 (Cth).

The sponsor must:

• be either an Australian resident or an incorporated body carrying on business in Australia, with a representative residing in Australia – an overseas manufacturer or supplier cannot act as the sponsor without an Australian-based presence;
• hold a TGA Client ID and be registered with the TGA via the TGA Business Services (TBS) portal before importing goods; and
• ensure – unless a specific exemption, exclusion or approval applies – that the product is on the ARTG before importation.

For overseas companies seeking to supply the Australian market without a local presence, the most common approach is to either establish a local subsidiary or engage an Australian-based third-party sponsor. The sponsor does not need to physically handle the goods; it can engage a third-party logistics provider or customs broker to do so.

Therapeutic goods must be included in the ARTG before they can be imported into, or exported from, Australia. For goods containing controlled substances (narcotics, psychotropics, precursors), a separate licence and/or permit from the Office of Drug Control is required under the Customs (Prohibited Imports) Regulations 1956 (Cth) before importation.

Note that the following exemptions may apply.

Special Access Scheme (SAS) and Authorised Prescriber (AP)

Unapproved therapeutic goods may be imported without ARTG inclusion for supply to individual patients (SAS) or a class of patients (AP), provided the goods are held under the direct control of the sponsor in a warehouse or properly secured area.

Clinical Trials

Goods imported for use in an approved clinical trial under the Clinical Trial Notification (CTN) or the Clinical Trial Approval (CTA) schemes are exempt from the ARTG requirement.

Medicine Shortages (Section 19A of the Therapeutic Goods Act)

The TGA can approve importation of a medicine not on the ARTG where there is a shortage of a registered medicine and it is needed in the interest of public health.

Personal Importation

Individuals may import a medicine for personal use without being included on the ARTG, provided it does not contain a prohibited substance and is within quantity limits, which is typically up to three months’ supply.

Exporting Medicines for Donation and Non-Commercial Exportation

Certain medicines exported for donation or non-commercial purposes are exempt from ARTG inclusion, provided they are not for commercial supply, do not contain prohibited export substances and are not for clinical trials.

The ARTG inclusion requirement is the primary non-tariff barrier in Australia. Depending on the nature of the product, specific non-tariff restrictions may include:

• controlled substance permits (the Customs (Prohibited Imports) Regulations 1956 (Cth)): for narcotics, psychotropics, and precursors, triggered by the substance’s scheduling status;
• biosecurity requirements (the Biosecurity Act 2015) for products containing biological material, administered by the Department of Agriculture at the border; and
• Good Manufacturing Practice (GMP) clearances – overseas manufacturing sites must hold TGA GMP clearance before their medicines can be imported.

Australia is a signatory to a large number of free trade agreements which concern therapeutic goods, including:

• the Comprehensive and Progressive Agreement for Trans-Pacific Partnership – includes a transparency annex for pharmaceuticals and regulatory coherence provisions;
• the Australia-United States Free Trade Agreement – contains a dedicated pharmaceutical annex addressing transparency in Pharmaceutical Benefits Scheme (PBS) pricing reimbursement, and IP protections;
• the Regional Comprehensive Economic Partnership – Australia’s largest free trade agreement (15 Asia-Pacific nations), with tariff elimination commitments on pharmaceutical and medical device products; and
• bilateral free trade agreements with China, Japan, South Korea, Singapore and others, which include zero or reduced tariffs on therapeutic goods.

Australia also participates in various regulatory co-operation arrangements, including the Access Consortium (work-sharing on medicine evaluations), the Pharmaceutical Inspection Co-operation Scheme (mutual recognition of GMP inspections) and the Medical Device Single Audit Program (single-audit recognition across the USA, Canada, Japan and Brazil).

Australia does not directly control prices for medicines or medical devices which are for private sale. However, for medicines subsidised through the Pharmaceutical Benefits Scheme (PBS), the government controls the amount that it will subsidise to the price of the medicine, which in practice sets a ceiling for the subsidised market. The PBS is governed by the National Health Act 1953 (Cth) and its delegated legislation.

Medicines can only be listed on the PBS once the Pharmaceutical Benefits Advisory Clinic (PBAC) has made a positive recommendation for listing, on the basis of clinical and cost effectiveness. If the PBAC recommends listing, the price is then negotiated between the sponsor and the Department of Health, Disability and Ageing on behalf of the Commonwealth, which becomes an “agreed price”. The approved ex-manufacturer price (AEMP) becomes the list price for the pharmaceutical benefit.

Depending on the level of competition in the market, PBS-listed medicines will be subject to statutory price reductions over time, including anniversary and other “one-off” price reductions, mandatory price cuts when generics or biosimilars enter the market, and periodic price disclosure cycles that adjust prices based on actual market transaction data.

The National Health Act, the National Health (Pharmaceutical Benefits) Regulations 2017 (Cth) and other legislative instruments, along with the Eighth Community Pharmacy Agreement between the Commonwealth and the Pharmacy Guild of Australia, and the First Pharmaceutical Wholesaler Agreement (1PWA) between the Commonwealth and National Pharmaceutical Services Association Limited, together set various elements of pricing that apply across the supply chain, including wholesaler mark-up and pharmacy dispensing fees. The particular requirements will depend on the type of medicine in question (eg, chemotherapy drugs or highly specialised drugs supplied in hospitals have different requirements).

In addition, the Commonwealth Government sets patient co-payment levels and a “Safety Net”, which ensure that costs to patients remain low, irrespective of the cost of the medicine to the government.

Medical device prices are not directly controlled by government. However, for devices used in public hospitals, pricing is effectively constrained by state/territory health department procurement and tendering processes. In addition, the Prescribed List sets maximum prices for certain device and tissue products that must be supplied under private health insurance cover.

“Prices of items containing the drug in reasonably comparable overseas countries” are one factor that the Department of Health, Disability and Ageing’s Pricing Section considers when negotiating prices with the sponsor for listing on the PBS. However, this is not an element of the PBAC’s task in providing recommendations as to whether a particular drug or medicinal preparation should be listed on the PBS. Most of the analysis is driven by domestic cost-effectiveness rather than direct cross-country price benchmarking. Overseas prices nevertheless remain a background consideration in pricing negotiations between the government and a company (“responsible person”) once the PBAC has made a positive recommendation for listing.

The PBS subsidises the cost of medicines listed on the Schedule of Pharmaceutical Benefits for all eligible Australian residents and overseas visitors from countries with which Australia has a Reciprocal Health Care Agreement (the UK, Ireland, New Zealand, Malta, Italy, Sweden, the Netherlands, Finland, Norway, Belgium and Slovenia). A medicine can only be listed on the PBS if the PBAC recommends it based on clinical effectiveness and cost-effectiveness.

The Australian public hospital system also subsidises pharmaceuticals and medical devices through state and territory health department budgets, generally via procurement processes. There are a limited number of other schemes that subsidise products or services for particular purposes and groups of people, such as the National Hearing Program, the National Diabetes Services Scheme and the National Disability Insurance Scheme.

Australia introduced health technology assessments (HTAs) in 1992, to ascertain the cost-effectiveness for PBS listings. The PBAC cannot recommend a medicine for PBS listing unless it is satisfied that the medicine represents value for money compared with existing therapies for an identifiable group of patients.

For medical devices and diagnostic services, the equivalent HTA body is the Medical Services Advisory Committee (MSAC), which assesses clinical effectiveness and cost-effectiveness before a service or device can be funded through the Medicare Benefits Schedule (MBS) or recommended for listing on the Prescribed List (for complex devices requiring full HTA process).

In Australia, prescribing is regulated at the Commonwealth and state and territory level. The PBS imposes restrictions on subsidised medicines at the Commonwealth level. There are three applicable tiers of prescribing restrictions on the PBS:

• unrestricted – no conditions; 
• restricted – limited to specific therapeutic uses; and
• authority required – the prescriber must obtain prior approval from Services Australia, either by phone or electronically, before prescribing.

The PBS limits the maximum quantity and number of repeats per prescription, requiring the patient to return to their prescriber for reassessment before continuing treatment. 60-day prescriptions have been available for eligible patients since 1 September 2023.

At the state and territory level, drugs and poisons legislation governs who may prescribe, what they may prescribe and under what conditions, particularly for Schedule 4 (prescription-only) and Schedule 8 (controlled drugs) medicines.

Dispensing is similarly regulated at the Commonwealth and state and territory level. Pharmacists must verify the validity of each prescription, confirm patient identity, and provide consumer medicine information at the point of dispensing.

Pharmacies must maintain dispensing records for all scheduled medicines (not just PBS medicines) in accordance with state and territory requirements, typically for a minimum retention period of two years.