Therapeutic Goods Administration (TGA)
Australia's regulatory authority for therapeutic goods — responsible for evaluating, assessing, and monitoring medicines, medical devices, biologicals, and blood products to ensure they meet acceptable standards of quality, safety, and efficacy.
255 Days
NCE Review (Cat 1)
175 Days
COR-B Pathway
eCTD
Mandatory Format
ARTG
National Register
ARGPM — Australian Regulatory Guidelines for Prescription Medicines
The Australian Regulatory Guidelines for Prescription Medicines (ARGPM) is the TGA's comprehensive guidance document that outlines the requirements and procedures for the registration of prescription medicines on the Australian Register of Therapeutic Goods (ARTG). The ARGPM provides detailed instructions on the data requirements, format, and structure for all categories of prescription medicine applications, ensuring consistency and quality in regulatory submissions.
The ARGPM is structured to align with the ICH Common Technical Document (CTD) format and covers all aspects of the registration process, from initial application through to post-market requirements. It serves as the primary reference for sponsors preparing applications for the TGA and is regularly updated to reflect changes in regulatory science, international harmonisation efforts, and legislative amendments.
ARGPM Structure
Part 1 — General Requirements
Covers the legal framework, application types, and general administrative requirements for prescription medicine registration in Australia. Includes guidance on the structure and format of submissions.
Part 2 — Quality (Chemistry and Manufacturing)
Detailed requirements for drug substance and drug product characterisation, manufacturing process validation, specifications, analytical methods, stability studies, and container closure systems.
Part 3 — Nonclinical Documentation
Requirements for pharmacology, pharmacokinetics, and toxicology studies. Covers single-dose and repeat-dose toxicity, genotoxicity, carcinogenicity, reproductive toxicity, and local tolerance studies.
Part 4 — Clinical Documentation
Requirements for clinical study reports, including biopharmaceutic studies, PK/PD studies, dose-response studies, pivotal efficacy trials, and safety data from the complete clinical development programme.
Part 5 — Product Information and Labelling
Requirements for the Australian Product Information (PI), Consumer Medicine Information (CMI), and labelling that must accompany all registered prescription medicines.
COR-B — Comparable Overseas Regulator Pathway
The Comparable Overseas Regulator – Abridged (COR-B) evaluation pathway is a streamlined registration process that allows the TGA to leverage assessment reports from comparable overseas regulators to expedite the approval of medicines in Australia. This pathway recognises that rigorous evaluations conducted by trusted international agencies can be used as the foundation for Australian regulatory decisions, significantly reducing review timelines and duplication of effort.
Under the COR-B pathway, sponsors submit the complete eCTD dossier along with the assessment report(s) from the comparable overseas regulator. The TGA then focuses its evaluation on Australia-specific considerations, including the appropriateness of the product for the Australian population, local labelling requirements (Product Information and Consumer Medicine Information), and any unique risk-benefit considerations relevant to the Australian healthcare context.
COR-B Eligibility
To be eligible for the COR-B pathway, the medicine must have been approved by at least one of the comparable overseas regulators listed below within the preceding 3 years. The approved indication and dosage form must align with the Australian application.
Recognised Comparable Overseas Regulators
US Food and Drug Administration (FDA)
United States
TGA can reference FDA approval decisions and assessment reports for medicines approved through NDA or BLA pathways.
European Medicines Agency (EMA)
European Union
EMA centralised procedure assessments (EPAR) are accepted as the basis for COR-B applications, including Committee for Medicinal Products (CHMP) opinions.
Health Canada (HPFB)
Canada
Health Canada NDS assessment reports and Notice of Compliance decisions can be used to support COR-B pathway applications.
Swissmedic
Switzerland
Swissmedic assessment reports for authorised medicines are accepted under the COR-B framework.
Application Categories
Category 1 — New Chemical Entity
New active substance not previously registered in Australia
Timeline: 255 working days
Category 2 — Extension of Indications
New therapeutic use for an already-registered medicine
Timeline: 175 working days
Category 3 — New Generic Medicine
Bioequivalent generic version of a registered medicine
Timeline: 175 working days
Category 4 — New Biosimilar
Biosimilar version of a registered biological medicine
Timeline: 255 working days
COR-B Pathway
Application based on comparable overseas regulator assessment
Timeline: 175 working days
eCTD Requirement
eCTD is the mandatory format for all prescription medicine applications to the TGA. All registration applications, variations, and associated regulatory activities must be submitted electronically in eCTD format via the TGA Business Services (TBS) portal. This requirement applies to all categories of prescription medicine submissions including NCEs, generics, biosimilars, and COR-B applications.
Key Regulations & Guidelines
Therapeutic Goods Act 1989
Primary legislation establishing the framework for the regulation of therapeutic goods in Australia
Therapeutic Goods Regulations 1990
Regulations made under the Act, providing detailed requirements for applications, evaluation, and registration
ARGPM (Australian Regulatory Guidelines)
Comprehensive guidelines for prescription medicine registration, providing detailed formatting and content requirements
Australian Register of Therapeutic Goods (ARTG)
The official register of all therapeutic goods approved for supply in Australia
ICH Guidelines (TGA-adopted)
International harmonised guidelines adopted into the Australian regulatory framework
PIC/S GMP Guide
Good Manufacturing Practice standards for pharmaceutical manufacturing aligned with international PIC/S standards
Reference Document
TGA ARGPM Guidance Manual
Official Australian Regulatory Guidelines for Prescription Medicines published by the TGA
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