Australia has a structured and risk-based regulatory framework that it uses for medicines. It is not a straightforward regulatory pathway. Several factors affect it. These include the type of medicine, its ingredients, intended indications, risk profile and the evidence required for its quality and safety. Registered medicines undergo pre-market evaluation. On the other hand, listed medicines follow a lower-risk route that’s based on permitted ingredients and indications. Assessed listed medicines sit between these pathways, with some efficacy claims evaluated before supply.
This blog covers the regulations laid by Australian authorities for pharmaceuticals and the process to follow.
Who Regulates Pharmaceuticals in Australia?
The Therapeutic Goods Administration (TGA). It is Australia’s national regulatory authority for therapeutic goods. It includes medicines. As a part of the Department of Health, Disability and Ageing, its regulated areas for medicines are as follows:
- Market authorisation and inclusion in ARTG
- Medicine quality, safety and efficacy
- Manufacturing and Good Manufacturing Practice (GMP)
- Labelling and packaging
- Clinical trials involving unapproved therapeutic goods
- Pharmacovigilance and post-market monitoring
- Regulatory compliance and enforcement
The Australian Register of Therapeutic Goods (ARTG) is the national database of therapeutic goods for legal supply in Australia. An ARTG entry belongs to a sponsor. That sponsor takes care of applying for and maintaining the entry and meeting relevant regulatory obligations.
Pharmaceutical Laws and Regulations in Australia
Pharmaceutical regulation in Australia is based on the Therapeutic Goods Act 1989 and associated legislative instruments and regulations. Several other standards and regulatory instruments apply. It just depends on the medicine and its intended use.
Therapeutic Goods Act 1989
The Therapeutic Goods Act 1989 is the principal Commonwealth legislation that governs therapeutic goods in Australia. It provides the legislative framework for matters that relate to the regulation, import, export, manufacture and supply of these goods. In this Act, companies’ll find important elements of the ARTG as well.
Therapeutic Goods Regulations 1990
These support the operation of the Act. It provides requirements across areas such as applications, exemptions, advertising, fees and other regulatory matters. Because the Regulations are amended periodically, companies will need to consult the current compilation. They shouldn’t rely on an old copy when preparing an application. The Federal Register currently identifies a compilation dated 8 September 2026.
Therapeutic Goods Orders
Therapeutic Goods Orders (TGOs) provide mandatory standards for particular aspects of therapeutic goods. For medicines, relevant orders may address areas mentioned below:
- Prescription medicine labelling
- Non-prescription medicine labelling
- Child-resistant packaging
- Microbiological standards
- Other product-specific requirements
The applicable TGO depends on the product and its regulatory characteristics.
Poisons Standard (SUSMP)
This is also known as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). It provides schedules for medicines and poisons according to the level of regulatory control required. The current instrument is the Therapeutic Goods (Poisons Standard—June 2026) Instrument 2026, which commenced on 1 June 2026. Scheduling affects controls concerning matters such as supply and availability and is also relevant to labelling and other regulatory requirements.
Classification of Medicines in Australia
Australia uses a risk-based framework for regulating medicines. The TGA broadly distinguishes medicines as registered or listed, but the listed category includes both ordinary listed medicines and assessed listed medicines.
1. Registered Medicines
Registered medicines are subject to TGA pre-market evaluation of quality, safety and efficacy. All prescription medicines are registered. Most OTC medicines and some complementary medicines are also registered. Registered medicines are identified by an AUST R number on their labels.
2. Listed Medicines
Listed medicines are lower-risk medicines containing permitted ingredients and making permitted indications. Sponsors self-certify that the medicine meets applicable legal requirements before listing it in the ARTG. The TGA does not routinely assess the product’s efficacy before listing, although listed medicines remain subject to post-market compliance monitoring. Listed medicines = AUST L number.
3. Assessed Listed Medicines
Assessed listed medicines occupy an intermediate position between ordinary listed medicines and registered medicines. They contain low-risk ingredients but may make quite higher-level health indications than ordinary listed medicines. The authorities evaluate the evidence supporting those indications before the medicine is listed. These products receive an AUST L(A) number and may use the permitted “TGA assessed” claim according to the requirements that apply.
4. Prescription, OTC and Complementary Medicines
The regulatory pathway also depends on the medicine type. These include the following:
- Prescription medicines: All prescription medicines are registered and undergo TGA evaluation.
- Over-the-counter (OTC) medicines: Depending on their risk and characteristics, OTC medicines may be registered, listed or assessed listed.
- Complementary medicines: Most complementary medicines are listed. Although some higher-risk complementary medicines are registered, some may follow the assessed listed pathway.
Pharmaceutical Registration and Market Authorisation Process in Australia
Market authorisation means the formal approval needed to supply a therapeutic good in Australia. For most medicines, this involves inclusion in the ARTG. The exact application pathway varies according to the medicine. But a prescription medicine may follow the process mentioned below:
- Choosing which regulatory pathway applies.
- Establishing the sponsor and TGA Business Services access.
- Preparing the required application. Completing the supporting dossier.
- Submitting the application through the TGA process that applies.
- Paying the applicable fees.
- TGA screening and acceptance of the application.
- Scientific evaluation of the submitted evidence.
- Responding to requests for further information where required.
- TGA regulatory decision.
- ARTG registration if the application is approved.
- Meeting continuing post-market obligations.
The TGA requires prescription medicine applications to include data that clarifies the product’s quality, safety and efficacy, together with completed forms and applicable fees.
The process varies for listed medicines. The sponsor here applies through TGA Business Services and self-certifies compliance with the relevant legislative requirements.
Dossier Requirements for Pharmaceutical Registration in Australia
The dossier requirements of TGA depend on the type of medicine and the applicable regulatory pathway. The Common Technical Document (CTD) provides the overall structure for organising the scientific and regulatory information for registered medicines submitted to the TGA.
For prescription medicines, the TGA requires applications to be submitted in electronic Common Technical Document (eCTD) format. The dossier must contain the information necessary for the TGA to evaluate the medicine’s quality, safety and efficacy.
CTD Structure for Medicine Applications
The CTD is organised into five modules:
| CTD Module | Main Content |
| Module 1 |
Administrative information and prescribing information specific to Australia
|
| Module 2 | Quality, non-clinical and clinical information – Summary |
| Module 3 | Quality details |
| Module 4 | Non-clinical study reports, including safety data |
| Module 5 | Clinical study reports and clinical data |
The TGA states that the actual content of a dossier depends on the application category and the type of medicine. Therefore, not every application will contain identical documentation in every module.
Module 1: Australian Administrative and Prescribing Information
Module 1 contains information specific to Australia. Depending on the application, this can include administrative information, application forms, prescribing information, proposed Product Information (PI), Consumer Medicine Information (CMI), labelling and other Australian-specific documentation.
The TGA’s CTD Module 1: Administrative information and prescribing information for Australia provides the applicable format and content requirements and explains when individual documents need to be submitted.
Modules 2 to 5: Scientific Data
For a registered medicine, the remaining CTD modules organise the scientific evidence supporting the application:
- Module 2: Quality, non-clinical and clinical information summary
- Module 3: detailed quality information relating to the drug substance and drug product
- Module 4: non-clinical study reports supporting safety
- Module 5: clinical study reports supporting efficacy and other clinical considerations
The TGA notes that the dossier should contain or reference the necessary data to demonstrate the quality, safety and efficacy of the prescription medicine.
Additional Dossier Information
Depending on the product and application, the dossier may also need supporting information such as:
- Stability data
- Impurity information
- Bioavailability, bioequivalence or biowaiver information, where applicable
- Drug Master File (DMF) information
- Certificates of Suitability (CEP), where applicable
- Manufacturing and GMP-related information
- Product Information and labelling documentation
- Relevant clinical and non-clinical studies
The TGA provides specific guidance and document matrices to identify the information required for particular application types. Applicants should therefore use the relevant TGA dossier checklist and document matrix rather than relying on a generic document list.
eCTD Submission Requirement
For prescription medicines, all applications, including master files, must be submitted in eCTD format under the current TGA requirements. eCTD can also be used for biologicals, OTC medicines, registered complementary medicines, assessed listed medicines and ingredients for listed medicines.
Before submitting an eCTD sequence, applicants need a TGA Business Services client account and an appropriate electronic identifier (e-ID). The TGA validates the submitted sequence and provides a validation result to the nominated contact.
Dossier Requirements for Non-Prescription Medicines
The TGA has a separate dossier framework for non-prescription medicines. For registered OTC and complementary medicines, the CTD structure consists of the same five broad modules, although the actual dossier content varies according to the application category.
For assessed listed medicines, the dossier is based on a simplified CTD structure.
TGA GMP Requirements for Pharmaceutical Products
The TGA currently applies the PIC/S Guide to GMP – 25 August 2023, PE009-17 to the manufacture of medicines, APIs and sunscreens, unless an applicable exemption applies. The updated requirements took effect from 1 September 2025. The framework covers manufacturing controls intended to ensure that medicines consistently meet appropriate quality standards.
Australian Manufacturers
Australian manufacturing sites must hold the appropriate TGA manufacturing licence for the relevant manufacturing activities.
Overseas Manufacturers
Overseas manufacturing sites do not obtain an Australian manufacturing licence. Instead, sponsors can apply for GMP clearance or GMP certification, depending on the applicable pathway.
The TGA may use inspection reliance and international regulatory arrangements when assessing GMP evidence from overseas regulators. However, evidence from another regulator is not automatically accepted. They assess the relevant regulatory authority’s GMP programme before relying on it.
Pharmaceutical Labelling and Packaging Requirements in Australia
Medicine labels must comply with the applicable Australian labelling standards. The requirements differ according to the medicine type. Important requirements include the following:
- TGO 91 for prescription and related medicines
- TGO 92 for non-prescription medicines
- Required Advisory Statements for Medicine Labels (RASML) where applicable
- TGO 95 for specified child-resistant packaging requirements
- Applicable requirements for Product Information (PI) and Consumer Medicine Information (CMI)
The TGA explains that labels communicate information critical to prescribers, pharmacists and consumers, including information needed for safe use.
AUST Numbers
Medicines included in the ARTG must mention the AUST R, AUST L or AUST L(A) number that’s applicable to them on the label.
Product Information and Consumer Medicine Information
Product Information (PI) contains technical information that shows the safe and effective use of a medicine. It includes indications, contraindications, precautions, adverse reactions, dosage and storage information.
Consumer Medicine Information (CMI) provides information for consumers about the safe and effective use of applicable prescription and specified OTC medicines. Current CMI requirements include standardised templates under the Therapeutic Goods Regulations.
Child-Resistant Packaging
TGO 95 establishes child-resistant packaging requirements for specified prescription, OTC and listed medicines.
Importation and Supply of Medicines in Australia
Medicines usually must be included in the ARTG before they can be legally imported into, supplied in or exported from Australia, unless a relevant exemption or other lawful pathway applies. Every ARTG entry is by a sponsor. That sponsor must maintain the entry and meet the relevant regulatory requirements. For commercial supply, the product imported into Australia must correspond to the version authorised for the Australian market.
Unapproved Medicines
Australia also has pathways under which certain unapproved therapeutic goods may be lawfully accessed or supplied. These include clinical trials, Special Access Scheme (SAS), and Authorised Prescriber Scheme. These pathways should not be confused with ordinary TGA market authorisation or ARTG registration.
Clinical Trial Requirements for Pharmaceuticals in Australia
Clinical trials involving unapproved medicines and biologicals may be conducted in Australia under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) schemes.
Clinical Trial Notification (CTN)
Under the CTN pathway, the TGA does not evaluate clinical trial data at the time of notification. The trial requires the appropriate approvals from the Human Research Ethics Committee (HREC) and the relevant approving authority. The Australian clinical trial sponsor is responsible for ensuring the required approvals are in place before supplying the unapproved therapeutic good under the trial.
Clinical Trial Approval (CTA)
Under the CTA scheme, the sponsor submits an application and supporting scientific information to the TGA. The TGA evaluates the therapeutic good, including relevant quality and safety information, before deciding whether the unapproved good may be supplied under the clinical trial.
Good Clinical Practice
The TGA has adopted ICH E6(R3) Good Clinical Practice. The new guideline took effect on 13 January 2026, with a 12-month transition period running until 13 January 2027. During this transition, applicable trials may comply with either E6(R2) or E6(R3), subject to the TGA’s requirements.
The TGA also operates a risk-based GCP Inspection Programme covering clinical trials of medicines, biologicals and devices conducted under the CTN or CTA schemes.
Regulatory Considerations for Generic, Biosimilar and Biological Medicines
The following considerations apply to these three medicine types:
1. Generic Medicines
It is an additional brand of an existing medicine. It has the same active ingredient. Generic medicines generally need to demonstrate bioequivalence to the relevant reference medicine where required by the applicable regulatory pathway. The TGA has a specific regulatory framework for registering new generic prescription medicines.
2. Biosimilar Medicines
A biosimilar is a version of an already registered biological medicine, known as the reference medicine. Biosimilarity is demonstrated through a comprehensive comparability exercise covering relevant physicochemical, biological, immunological, efficacy and safety characteristics. Biosimilar medicines are regulated within the prescription medicine framework.
3. Biological Medicines
These are regulated as prescription medicines in Australia. They require the applicable evidence supporting quality, safety and efficacy for inclusion in the ARTG. This should not be confused with the separate regulatory category of biologicals, which covers different types of products and has its own regulatory framework.
Pharmaceutical Registration Timelines in Australia
There is no single TGA registration timeline applicable to every medicine. The timeframe depends on the type of medicine, application category, pathway, completeness of the submission, evaluation requirements and the time taken by the sponsor to respond to TGA requests.
For the established prescription medicine registration process, the TGA states that the process is designed to take an average of approximately 330 calendar days (11 months), including applicant activities. The legislated period from acceptance for evaluation to the delegate’s decision is 255 working days, although this is not itself presented as a guaranteed approval time.
Priority Review
The priority review pathway is available for eligible vital and life-saving prescription medicines. The TGA states that the target timeframe is 150 working days, while the same legislative timeframe of 255 working days applies to the standard pathway. Eligibility requirements apply.
Provisional Registration
Australia also has a provisional registration pathway intended to facilitate earlier access to promising new medicines in specified circumstances. Therefore, companies should avoid treating 330 days as a guaranteed approval period.
Cost of Pharmaceutical Registration in Australia
There is no single registration fee applicable to every medicine as it depends on the product and pathway. The TGA publishes an updated fee and charge schedule each financial year. The current schedule applies from July 2026, so companies preparing an application in 2026 should use the current schedule rather than older fee figures. TGA costs can include:
- Application fees
- Evaluation fees
- Fees associated with particular regulatory services or variations
- Annual charges for maintaining eligible ARTG entries
- GMP-related regulatory fees where applicable
The TGA operates on a cost-recovery basis. A fee is generally charged for a regulatory service, such as product evaluation, while an annual charge applies to relevant regulated products on an ongoing basis. An Annual Charge Exemption (ACE) scheme can provide an exemption from annual charges until an eligible product first generates turnover, subject to the applicable requirements and declarations.
Pharmacovigilance and Post-Market Obligations
TGA approval or ARTG inclusion does not end a sponsor’s regulatory responsibilities. Sponsors have continuing obligations to monitor the safety of their medicines and report relevant safety information. For medicines registered or listed in the ARTG, sponsors are legally responsible for meeting applicable pharmacovigilance requirements. These responsibilities include the following:
- Identifying an Australian pharmacovigilance contact person
- Reporting serious adverse reactions
- Notifying significant safety issues
- Maintaining appropriate safety records
- Responding to TGA requests for information
- Monitoring safety information from relevant sources
Adverse Event Reporting
Sponsors can report medicine and vaccine adverse events through the TGA’s Adverse Event Management System (AEMS), electronic data interchange or, where applicable, a CIOMS form. The TGA states that serious Australian adverse reactions must be reported within 15 calendar days of first receipt.
Other Post-Market Responsibilities
Post-market compliance can also involve the following:
- Safety monitoring
- Product recalls and corrective actions
- Medicine shortage notifications where applicable
- Changes to product information
- Regulatory variations
- TGA post-market reviews
The TGA maintains specific monitoring and compliance requirements for sponsors of prescription medicines.
Recent TGA Enforcement Action: BioV8 Peptide Advertising Case
TGA began their Federal Court proceedings in September 2026. They started it against A.C.N. 641 483 703 Pty Ltd (in liquidation). It was formerly BioV8 Pty Ltd. Their two former directors were alleged unlawful advertising of therapeutic goods, including peptide products. Their brief statement was lodged with the Federal Court of Australia on 15 September 2026.
TGA alleged that the conduct occurred between 6 June 2024 and 14 July 2025. It involved advertising through the BioV8 website, Instagram, Facebook, and YouTube. The products included peptides like BPC-157, CJC-1295, and GHRP-6.
The allegations cover advertising products that have Schedule 4 substances without the needed authorization. They were referring to therapeutic goods that were not made a part of the Australian Register of Therapeutic Goods (ARTG). Also, they were making prohibited or restricted representations concerning serious conditions. The concise statement also alleges that some advertisements contained claims that products were safe. Or, they were without side effects, infallible or miraculous, even exaggerating their efficacy or performance.
The importance of advertising governance across digital channels is also highlighted by this case. The alleged non-compliance extended beyond product webpages to social media and YouTube. At the same time, the statement identifies the potential responsibility of individuals who controlled or influenced the advertising content.
The Secretary is seeking declarations, pecuniary penalties, and costs. However, these remain allegations before the Court and should not be presented as established findings of liability.
Regulatory Takeaway From This Case
The BioV8 proceedings reinforce the need for pharmaceutical and therapeutic-goods companies to review:
- Prescription-only product advertising
- Claims made on websites and social media
- Prohibited and restricted disease representations
- ARTG status before promoting therapeutic goods
- References to Schedule 4 substances
- Evidence supporting efficacy and safety claims
- Scientific or clinical references used in advertising
The TGA has also stated that it is increasing attention on unapproved peptide products. It is quite a relevant development for businesses involved in peptide products, telehealth, compounding, or digital promotion.
Conclusion
Pharmaceutical regulation in Australia is based on a risk-based framework administered principally by the Therapeutic Goods Administration. Depending on the medicine and its characteristics, a product may follow a registered, listed or assessed listed pathway before it can be legally supplied in Australia.
For support with pharmaceutical registration, regulatory compliance, GMP, labelling, and post-market requirements, explore Artixio’s pharmaceutical regulatory and compliance services.
For specific regulatory support, contact us at info@artixio.com.
FAQs
1. Is TGA registration mandatory for medicines in Australia?
Generally, medicines must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be legally imported, supplied or exported in Australia, unless an exemption, exclusion or another lawful pathway applies.
2. How are AUST L, AUST R and AUST L(A)?
AUST R – registered medicine. AUST L identifies a listed medicine, and AUST L(A) identifies an assessed listed medicine. Registered and assessed listed medicines undergo pre-market efficacy assessment, while ordinary listed medicines do not.
3. Does an overseas pharmaceutical manufacturer need an Australian GMP licence?
No. Australian manufacturing sites can hold TGA manufacturing licences, while overseas manufacturers can obtain GMP clearance or certification through the applicable TGA process.
4. What are the main ongoing obligations after medicine registration?
Sponsors must continue to comply with applicable requirements, including pharmacovigilance, adverse-event reporting, safety monitoring, product information, manufacturing and other post-market obligations.
