Life Sciences 2025 Comparisons

The Therapeutic Goods Act 1989 (Cth) (the “TG Act”) is the primary legislation governing therapeutic goods in Australia. Alongside multiple regulations and orders, the TG Act provides a framework and legal requirements for the importing, exporting, manufacturing and supplying of therapeutic goods. The Therapeutic Goods Regulations 1990 (the “TG Regulations”) further regulate pharmaceuticals and biologicals. Medical devices are specifically regulated by the Therapeutic Goods (Medical Devices) Regulations 2002 (the “TG MD Regulations”).

The Therapeutic Goods Administration (the “TGA”) is the primary authority responsible for regulating pharmaceuticals and medical devices in Australia. It is semi-autonomous but is a government authority and reports to the Federal Department of Health.

A wide range of TGA decisions are subject to review, first by the Federal Minister for Health (or their delegate) and subsequently to the Administrative Review Tribunal (the “ART”). Both the Minister and the ART undertake the review on a merits basis, effectively substituting their own judgment for that of the decision-maker. These reviews are available as of right and no further steps are necessary to challenge.

TGA decisions are also subject to judicial review under the Administrative Decisions (Judicial Review) Act (the “ADJR Act”). These decisions are not reviewed on the basis of the validity of the decision, but instead on the process by which the decision was reached. These reviews are again available as of right and no further steps are necessary to challenge. The ADJR Act also allows persons affected by decisions to seek a statement of reasons from the decision maker, before mounting a challenge.

Challenges to food products and other regulated products are subject to different regulatory regimes and therefore different procedures for challenge. However, the right to review under the ADJR Act typically remains.

Both pharmaceuticals and medical devices as well as third category “biologicals” are regulated differently depending on the risk associated with the products.

In respect of pharmaceuticals, the TG Act differentiates between registered medicines and listed medicines. Listed medicines are lower risk products, typically complementary medicines and nutraceuticals, which are subject to restrictions on ingredients and therapeutic claims. Registered medicines contain all other medicines, which are subject to similar regulation at the national level. At the State level, pharmaceuticals are regulated differently by way of scheduling as pharmacy-only, pharmacist-only, prescription-only and controlled substances. The scheduling of medicines occurs in line with the national Poisons Standard.

Medical devices are classified into four classes (with certain sub-classes) according to their risk. While all medical devices must be registered in Australia before import, manufacture, export and supply, the requirements for registration and ongoing compliance differs between classes. The Australian classification of medical devices essentially aligns with the European classifications.

Four classes are also established for biologicals. Class 1 biologicals (currently limited to faecal microbiota transplant products) are subject to self-certification. Other classes are subject to review by the TGA before registration.

The TGA regulates clinical trials of unapproved therapeutic goods through the Clinical Trial Notification (the “CTN”) and the Clinical Trial Approval (the “CTA”) schemes, as established by the TG Act, the TG Regulations and the TG MD Regulations. All clinical trials must be conducted in line with the “National Statement on Ethical Conduct in Research Involving Humans” issued by the National Health and Medical Research Council (the “National Statement”). Clinical trials for medicines and biologicals must also comply with the ICH Good Clinical Practice Guideline.

In respect of the CTN scheme, the review and approval of the protocol and ongoing oversight of the trial are controlled by a Human Research Ethics Committee or HREC at the relevant trial site. The sponsor, following ethics approval must notify the TGA before the trial commences. The TGA also exercises some oversight of a trial, particularly first-in-human trials or where the TGA otherwise has concerns about the trial.

In respect of the CTA scheme, the review and approval of the protocol is undertaken by the TGA. This is typically only applied to goods with new technology and/or high-risk products, such as Class 4 biologicals. Ethics approval is also required. Oversight of the trial is undertaken by both the TGA and the HREC at the relevant trial site.

When deciding whether to approve the trial, the TGA will consider any pre-clinical and early clinical scientific data gathered in the early stages of product development. Parties seeking authorisation through the CTA scheme are advised to communicate with the TGA for pre-submission advice.

Under the CTN scheme, the sponsor must complete an online form to notify the TGA of its intention to commence a clinical trial. The TGA also has the power to request further information from the sponsor if there are any missing elements or trial concerns.

The TG Act and TG Regulations do not mandate registration of clinical trials in Australia. However, it is recommended and common and many HRECs insist upon it as a condition of approval. The National Statement also requires specific research projects to be registered on a publicly accessible register before recruitment commences. This means registration of clinical trials is effectively becoming mandatory. When registered, data is made available on the Australia New Zealand Clinical Trials Registry (the “ANZCTR”). The ANZCTR contains data from trials concerning a range of therapeutic goods, including both medicines and medical devices. Data from registered studies offers a vast amount of information, including information about the study, recruitment status, demographics of participants, funding source type and phase.

The use of digital technology is generally permitted when operating clinical trials. Many Australian trial sponsors employ online tools to recruit trial participants, conduct trials virtually, manage data and monitor results. Sponsors must nevertheless remain aware of good clinical practice principles and laws surrounding confidentiality, discrimination and privacy. The relevant HREC will usually review the information being sought from trial participants and the basic functionality of those tools.

Data resulting from clinical trials is sensitive information and has to be treated in line with the Privacy Act 1988 (Cth) and the associated Australian Privacy Principles, as well as State and Territory health privacy legislation.

However, information transmitted to sponsors does not include any details that could identify individual trial participants. In this case, there are fewer restrictions on the collection, use and disclosure, including transfer to third parties and affiliates. These issues are also typically dealt with by way of explicit consent within the participant informed consent form.

A database containing personal or sensitive data will be subject to further legal requirements concerning electronic records, privacy, authorised personnel, data security and export. Much depends on the terms of the requisite consent obtained at the time the information is collected from the relevant individual.

Medicines and medical devices are two of the main therapeutic goods regulated by the TGA. Assessing whether a product is a medicine or a medical device requires the definitions under the TG Act to be referred to. These specify criteria based on the means though which intended action of the good takes place. For example, medicines are essentially defined as goods which “are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human”. Medical devices are articles used for a range of specified therapeutic purposes which do not achieve their principal intended action in, or on, the human body by pharmacological, immunological or metabolic means.

Complexities may arise when a product may have attributes which fall into both categories or perhaps fall completely outside the scope of the definition. In this scenario, regulation will typically be determined depending on the primary intended purpose of the product.

Biological medicines are treated as medicines for regulatory purposes in Australia. When seeking authorisation for prescription medicines, parties must submit an application to the TGA with supporting documentation such as comprehensive data concerning the quality, safety and efficacy of the product.

The registration or listing of medicines and medical devices remain valid indefinitely unless the registration is cancelled by the sponsor or the TGA. Nonetheless, sponsors must pay an annual charge for each product on the ARTG, unless the product is export-only or if the charge has been waived by the TGA.

Medical devices in Australia are subject to ongoing conformity assessment procedures, which typically rely upon certificates issued in other jurisdictions (particularly Europe). These certificates typically have a three-year term. At this point they need to be renewed and failure to do so will impact upon the ongoing validity of the product registration in Australia.

Variation of the conditions associated with a marketing authorisation can occur instantly, where the TGA forms the view that the action is necessary to prevent imminent risk of death, serious illness or serious injury. Otherwise conditions can be imposed so long as 20 working days’ notice is given.

Suspension or cancellation can occur where the TGA considers that there has been a failure to comply with conditions or statements made in connection with an application were false or misleading. Cancellation can also occur where the TGA forms the view that the failure to cancel the registration will create an imminent risk of death, serious illness or serious injury. In these circumstances, the TGA may suspend the registration instead. In this case the sponsor may be able to address the TGA’s concern within the suspension period.

The specific requirements for product registration differ depending on the type of good as well as its classification. The TGA has Australian Regulatory Guidelines for prescription medicines, over-the-counter medicines and listed/complementary medicines and medical devices, which set out detailed information regarding the procedure for obtaining a marketing authorisation.

For prescription medicines, applications involve a pre-submission planning phase, allowing the TGA to identify relevant process milestones and manage resources accordingly. The required information has to be submitted as a dossier in line with the ICH Common Technical Document specifications. Following the submission of the dossier, the TGA carries out its review subject to statutory timeframes for review, which can be extended by requests for information.

For medical devices, Australia largely follows the EU system, including the use of conformity assessment certificates. The TGA permits sponsors to rely on certificates from a range of overseas regulators which can abridge assessment for the TGA’s conformity assessment procedure as well as for assessment of products. Reliance on overseas certificates is commonplace in Australia to the point where it is almost universal. Following the submission of the application, the TGA will either include the product in the ARTG, refuse the application if information is missing or audit the application. Audits of applications typically only occur for higher-risk medical devices, although the TGA can audit any application it chooses. This decision is made within 20 working days of submission.

The procedure for varying a marketing authorisation is likewise dependent upon the type of good as well as the type of variation. Where the variation requires the TGA to review clinical, pre-clinical or bioequivalence data, this goes through the same process as an initial registration. Other specific variations require notification to the TGA only and are not subject to review.

The transfer of an ARTG entry is a simple process. An entity which holds a marketing authorisation may transfer it to another Australian person or entity at any time. The entity receiving the marketing authorisation must notify the TGA within three months.

Medicines and medical devices which are not subject to marketing authorisation are subject to a range of exemptions. The most relevant of these are goods used in clinical trials, goods for compassionate use, goods imported personally by the end user and medicines extemporaneously compounded for a particular patient. Sponsors are also able to import products before approvals/exemptions are given, provided that these products are held under the sponsor’s control until approved/exempt.

Sponsors have to ensure that they remain vigilant about their medicines and/or medical devices on the ARTG. They may be committing offences and have penalties imposed on them if they fail to comply.

Sponsors have a legal responsibility to engage in pharmacovigilance with respect to their medicinal products registered or listed on the ARTG. This includes an obligation to: submit adverse action reports to the TGA within 15 days of becoming aware of them; notify the TGA of significant safety issues within 72 hours of becoming aware of them; assist TGA investigations by answering any requests for relevant information; and keep relevant records in line with the TG Act. The Australian authorities have also adopted the pharmacovigilance guidelines of the EU. To manage these ongoing obligations, sponsors of medicines are required to establish and maintain a pharmacovigilance system to record, investigate, analyse and report the relevant data.

Sponsors of medical device products have similar ongoing obligations as a result of mandatory post-market requirements. These include: keeping distribution records for five or ten years depending on the class of the device; reporting relevant adverse events; complying with requests from the TGA in a post-market review or investigation; and submitting annual reports regarding safety and performance for the first three years of authorisation.

The TGA may also impose further conditions on a sponsor’s product registration or listing at the time it is authorised or at a later date. For example, a sponsor may be required to deliver periodic safety update reports.

The TGA publishes a list of applications for new medicines and new indications that are under review. This does not include generic or biosimilar medicines. The information is very high-level and typically only contains the active ingredient, trade name, name of the applicant and a summary of proposed indications.

After grant or refusal, the TGA publishes Australian Prescription Medicine Decision Summaries (“AusPMDS”) and Australian Public Assessment Reports (“AusPARs”). AusPMDSs are only a high-level summary, typically compiled using the ARTG entry and product information. AusPARs are more detailed and include the steps and outcomes of evaluation that led to the TGA decision. While AusPARs will be published for all new entities and fixed combinations, other applications are at the TGA’s discretion and are only published where the significance of the submission to the public is considered to be high.

AusPARs include: background about the product; the major milestones reached in the application process; a summary of the risk/benefit assessment; and details about the regulatory outcome, including conditions applying to the goods. Sponsors are given an opportunity to review an AusPAR before it is published to identify any commercially confidential information or personal information to be removed, although these may need to be justified where there is disagreement.

The TGA has adopted the European Medicines Agency definition of commercially confidential information, which relates to intellectual property, know-how, trade secrets and “commercial confidences“. Information in the public domain is not protected.

The TGA has established two pathways to expedite the registration process for medicines and one to expedite the registration process for medical devices. These pathways are designed to ensure that patients have timely access to important and potentially life-saving treatments.

The Priority Review Pathway is available for pharmaceuticals that are intended to treat, prevent or diagnose a life-threatening or “seriously debilitating’” condition, where there are either no other treatments available or the treatment provides a significant improvement in the safety or efficacy of treatment, prevention or diagnosis of the condition. The TGA must also be satisfied that there is “substantial evidence” demonstrating that the medicine provides a major therapeutic advance. The TGA aims to complete the evaluation of priority review applications within 150 working days, compared to the usual 225 working days. Sponsors must seek a priority applicant determination from the TGA first and then make the formal application for registration within six months of notification.

The Priority Review Pathway also exists for medical devices to expedite the TGA conformity assessment or an application for inclusion in the ARTG.

The TGA also has a Provisional Approval Pathway which is intended for pharmaceuticals that address unmet clinical needs and have preliminary clinical data suggesting a significant benefit over existing treatments. Provisional approval enables early access to medicines based on less comprehensive clinical data, with the requirement that additional data will be provided post-approval to confirm the medicine’s safety and efficacy. Provisional approvals remain in effect for a period of two years and can be extended for two additional two-year periods.

Regulatory reliance is commonplace in Australia for medical devices. The TGA often relies upon overseas regulators to satisfy compliance with the conformity assessment procedures and streamlined approval processes.

In relation to medicines, the TGA has identified a list of comparable overseas regulators whose assessments it can rely on (in part). In these circumstances, the TGA will review the reports of the overseas regulator rather than the full dossier, as well as the label, product information and risk management plan (where required).

The TGA also engages in collaborative reviews of new treatments with overseas regulators, including, Project Orbis for cancer treatments, for example.

Each pharmaceutical manufacturing facility has to be licensed by the TGA in line with the TG Act and the TG Regulations.

The process for obtaining authorisation involves an application, followed by an audit by the TGA against the PIC/s Guide to Good Manufacturing principles. The application involves notifying the TGA of the relevant individuals who are responsible for quality control, production and release for supply as well as details of the items to be manufactured and the relevant manufacturing steps that are carried out. Applicants must also provide a site master file and a statutory declaration, confirming that relevant key stakeholders have not been convicted of relevant offences relating to therapeutic goods.

Overseas entities which wish to manufacture products for supply in Australia are also subject to Good Manufacturing Practice approval. This can be undertaken by the TGA, although it is typically undertaken by way of mutual recognition of a foreign regulator’s inspection of the relevant site.

A manufacturing licence remains in effect indefinitely, subject to the ongoing audit requirements of the TGA.

Local manufacturing also requires approval by the State or Territory Health Department in which the manufacturing site exists.

Manufacturers of medical devices do not require a licence to manufacture in Australia. However, manufacturers of medical devices which are included in the ARTG are subject to a range of requirements in respect of certification of their quality management system. Manufacturing a medical device which is not included in the ARTG or otherwise exempt is prohibited.

Licences for wholesalers of medicines are provided by the health department of each State and Territory. A wholesaler licence in any State typically permits wholesale in other States and Territories.

The process to obtain the authorisation varies between the States and Territories but largely relates to ensuring that the relevant premises is suitable for the relevant purposes. Suitability is assessed with reference to the Australian Code of Good Wholesaling Practice, which covers the proper handling, storage and distribution of pharmaceuticals and medical devices to maintain their quality and integrity. Other requirements are also imposed depending on the nature of the goods to be stored, particularly having regard to vaults necessary to store prescription and controlled substances.

Wholesale licences are typically granted for indefinite periods, subject to audit and renewal fees.

Wholesale licences are not required for medical devices.

The Poisons Standard establishes a national classification system. This controls how pharmaceuticals are made publicly available. The Schedules to the Poisons Standard are given legal effect through State and Territory legislation.

These classifications include:

• Schedule 2: medicines which can only be supplied at pharmacies;
• Schedule 3: medicines which can only be supplied by a pharmacist;
• Schedule 4: prescription-only medicines;
• Schedule 8: controlled drugs;
• Schedule 9: prohibited substances; and
• Schedule 10: Substances of such danger to health as to warrant prohibition of sale, supply and use.

There are also additional classifications (Schedules 5, 6 and 7) which apply to poisons.

The TGA regulates the importation and exportation of pharmaceuticals and medical devices in Australia. This is done through the TG Act and is supported by the TG Regulations, the TG MD Regulations and other legislative instruments.

The import and export of pharmaceuticals and medical devices is also subject to the Customs Act 1901 and subordinate regulations, particularly the Customs (Prohibited Imports) Regulations and Customs (Prohibited Export) Regulations. These instruments provide the framework for the import and export of all products, particularly having regard to products which cannot be imported or exported without approval.

Any Australian resident, whether an individual or company, can act as the importer of record for pharmaceuticals and medical devices. For the purposes of the TG Act, the importer is the sponsor of the product and therefore has obligations in respect of registration and ongoing compliance.

There are no other specific requirements to be able to act as the importer of record.

The importation of pharmaceuticals and medical devices into Australia is subject to strict regulatory controls to ensure the safety, efficacy and quality of these products. In most instances, these include the product on the ARTG, which typically involves review and approval by the TGA.

There are several exemptions regarding the requirement for authorisations for the importation of pharmaceuticals and medical devices, some of which include:

• personal importation scheme: individuals can import a three-month supply of unapproved therapeutic goods for personal use without the need for ARTG listing, provided the goods are not prohibited imports and meet specific conditions. The individual must have a prescription from an Australian-registered medical practitioner if the product is a prescription medicine;
• special access scheme (SAS): this scheme allows healthcare practitioners to access therapeutic goods that are not included in the ARTG for a single patient on a case-by-case basis. This is often used for compassionate access;
• authorised prescriber scheme: medical practitioners can become authorised prescribers of unapproved therapeutic goods for specific patients or groups of patients with particular medical conditions. This allows the prescriber to import these goods without the need for individual SAS applications; and
• clinical trials: products can be imported for clinical trials subject to approvals.

Products may also be imported without approval, provided that they are held under the direct control of the sponsor and only until such time as the product is subject to approval under another exemption or formally registered/included on the ARTG.

Non-tariff regulations and restrictions are typically imposed based on a technical description of the products. These restrictions are predominately concerned with ensuring that products do not present an unacceptable biosecurity risk to Australia. The restrictions are set out in the Australian Biosecurity Import Conditions Database (the “BICON”).

The Harmonised System (“HS”) Code is used to classify traded products and determine applicable tariffs and non-tariff measures. For pharmaceuticals and medical devices, specific HS Codes may be subject to particular import permits, licences or restrictions as set out in the TG Act and subordinate regulations typically.

Australia is a member of several trade blocs and is a party to 18 free trade agreements with more than 20 countries. Many of these agreements contain provisions on trade and regulatory facilitation of pharmaceuticals and medical devices.

There is no mandatory price control which sponsors of medicines or medical devices are subject to.

However, Australia operates a broad single-payer healthcare system, which includes subsidised access to medicines. The majority of medicines, particularly higher cost products, are only commercially viable in Australia if supplied through the Pharmaceutical Benefits Scheme (the “PBS”). The PBS is established under the National Health Act 1953 (Cth).

In order to be listed on the PBS, product prices are negotiated with the Federal Department of Health. Products are then supplied through the traditional supply chain, with wholesalers and pharmacists permitted to include specified agreed mark-ups to product prices. Pharmacists are then able to sell medicines to patients and seek reimbursement from the Federal government for the product.

In respect of medical devices, private health insurers are required to pay benefits for medical devices listed within the Prescribed List of Medical Devices and Human Tissue Products (the “Prescribed List”). The Prescribed List is contained within a set of rules created under the Private Health Insurance Act 2007 (Cth). The Medical Services Advisory Committee (the “MSAC”) assesses products and recommends whether they belong on the Prescribed List. The precise amount to be reimbursed for the product is agreed upon between the sponsor and the Federal government.

The price level of a pharmaceutical or medical device is not directly impacted by the price for the same product in other countries.

The costs of pharmaceuticals and medical devices are reimbursed from public funds primarily through the PBS and the Prescribed List.

The PBS subsidises the cost of prescription medications. To be included in the PBS, a drug must be recommended by the Pharmaceutical Benefits Advisory Committee (the “PBAC”) based on its efficacy, safety and cost effectiveness. Patients typically pay a co-payment, with the Federal government covering the remaining cost.

For medical devices, the Prescribed List ensures that private health insurance covers the cost of specific devices used in hospital treatments. Devices must be clinically effective and cost effective to be listed. Public hospitals also provide specific medical devices at no direct cost to patients, funded through State and Federal health budgets.

Reimbursement is contingent on the approval of the respective governing bodies and the clinical necessity of the treatment. These schemes aim to balance patient access to essential treatments with the sustainability of public health funding.

In Australia, cost-benefit analyses are applied in health technology assessments (“HTAs”) to determine the price of, and reimbursement for, pharmaceuticals and medical devices through a structured process involving the PBAC and the Medical Services Advisory Committee (the “MSAC”). The primary economic evaluation approaches used are cost effectiveness analysis (“CEA”) and cost utility analysis (“CUA”).

For reimbursement, the PBAC and the MSAC evaluate submissions based on clinical effectiveness, safety and cost effectiveness. They consider various factors, including the severity of the condition, unmet clinical need and equity implications. The committees use a deliberative process that incorporates both quantitative and qualitative evidence, including patient-reported outcomes and stakeholder input.

Pharmaceuticals and technologies that demonstrate favourable cost effectiveness and address significant health needs are more likely to be recommended for reimbursement under the PBS or the Medicare Benefits Schedule. Pricing is typically recommended on a cost minimisation basis against equivalent or relevantly comparable products unless sponsors can demonstrate a significant improvement in safety or efficacy.

The regulation of prescriptions by doctors and the dispensing of medications by pharmacies is primarily governed by poisons legislation in the States and Territories, with secondary regulation by the Australian Health Practitioners Regulatory Authority (the “AHPRA”) and the National Health Act.

Poisons legislation in the State and Territories dictates which individuals can write prescriptions and in what circumstances. This extends beyond physicians to include specialists and nurse practitioners. It also regulates which individuals and entities can possess and supply medicines.

The National Health Act also permits the Federal government to limit the circumstances in which physicians can prescribe reimbursed medicines, including in respect of indications, lines of therapy and key patient indicators/markers. This is intended to limit off-label use for reimbursed therapy, particularly where the cost effectiveness of the product in different patient cohorts may not have been properly tested.

Dispensing by pharmacists of reimbursed medicines is also regulated by the National Health Act. Pharmacists must be approved under the National Health Act and have to provide relevant information to the Federal Department of Health in order to be reimbursed.