Market authorisation is the formal approval required to supply a therapeutic good in Australia. In most cases, this includes entering the product in the Australian Register of Therapeutic Goods (ARTG).
To obtain market authorisation, you must submit a complete application via the TGA Business Services (TBS) portal. Your application must be supported by data demonstrating the quality, safety, and efficacy of the medicine, and you are required to pay applicable fees.
We assess this information to ensure it meets all regulatory standards. If the product complies with requirements, market authorisation is granted, the product is added to the ARTG, and it becomes legally available for supply in Australia.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to prescription medicines. You may also have to meet obligations that apply to all medicines and all products.
Application pathways and processes
Find application routes to market approval.
-
PageInformation on prescription medicine application pathways.
-
PageOrphan drug designation allows for a waiver of the application and evaluation fees to register drugs that treat rare medical conditions.
-
PageThe priority review pathway is a formal mechanism for faster assessment of vital and life-saving prescription medicines.
-
PageThe provisional registration pathway expedites early access to promising new medicines. This is for a limited time while you conduct clinical studies to confirm the medicine's benefit.
-
PageThe ARGPM will help you navigate the regulatory requirements for prescription medicines in Australia.
-
PageLinks to information on how the Therapeutic Goods Administration (TGA) uses assessments from comparable overseas regulators (CORs).
-
User guideThis is a step-by-step guide for agents and sponsors who wish to apply for Priority review, Provisional determination or Orphan drug designation of a prescription medicine.
-
FormsChecklist to assist in a priority review designation application
-
FormsThis checklist is to be used by sponsors to apply for priority review determination
-
FormsThis checklist is intended to assist applicants to determine if they have provided all the necessary information to allow the TGA to make an informed decision on the determination application.
-
-
GuidanceGuidance on how to prepare your application for orphan drug designation so that it meets eligibility criteria and requirements.
-
GuidanceThis guidance helps sponsors understand the eligibility criteria and supporting documentation required for a medicine to be eligible for priority determination.
-
GuidanceGuidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination.
-
PageFind out about our clinical evaluation streams and the functions each unit provides.
-
PageApproved determinations and designations for prescription medicines
-
GuidanceGuidance on the process and regulatory requirements to register prescription medicines.
-
GuidanceGuidance on how we make use of assessments from comparable overseas regulators (CORs).
Pre-submission planning
Access requirements for pre-submission planning and meetings.
-
PageGuidance on the submission requirements for the prescription medicines COR report-based process.
-
PageEvaluation plan estimators to approximate dates of milestones in the prescription medicine registration process.
-
User guideInstructions for applicants on how to organise and fill out a pre-submission planning form (PPF).
-
-
FormsUse these forms to request a meeting and to record agenda items and outcomes.
-
PageInformation about the pre-submission planning form (PPF) for prescription medicine applications.
-
PagePre-submission planning is the first phase of the prescription medicines registration process.
-
PageInformation for sponsors on demonstrating stability of medicines under Australian conditions.
Fees and charges
Understand fees, exemptions and how to make payments.
-
GuidanceGuidance for sponsors on the eligibility criteria for reduced application and evaluation fees for major variation applications for prescription medicines.
-
GuidanceGuidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.
Dossier preparation
Learn how to prepare and submit your dossier.
-
PageHow to compile a baseline sequence when transitioning your dossier from non-eCTD electronic submission (NeeS) to eCTD format.
-
-
GuidanceThis guidance explains the administrative and prescribing (dossier) information you need to support the registration or variation of a prescription medicine.
-
FormsComplete this form when submitting a new DMF to TGA, or when updating an existing DMF already held by the TGA.
-
PageInformation for sponsors and applicants preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines.
-
FormsA list of TGA forms for prescription medicine sponsors.
-
PageLearn the main terms and concepts for sending data to us in electronic eCTD format.
-
GuidanceGuidance on submitting an effective prescription medicines application.
-
-
PageTechnical rules for ensuring your NeeS sequence is valid.
-
FormsSubmission dossier checklist for prescription medicines
-
PageThis page is for industry stakeholders (e.g. manufacturers of active pharmaceutical ingredients) who provide Drug Master Files (DMF) to the TGA
-
PageHow to submit data in the Electronic Common Technical Document (eCTD) format.
-
PageHow to submit applications, reports and documentation in the electronic common technical document (eCTD) and non-eCTD electronic submission (NeeS) formats.
-
PageFind out how to submit your prescription medicine application and dossier.
-
GuidanceGuidance on the two mechanisms to provide information about a drug substance sourced from a third-party manufacturer.
-
PageData the TGA evaluates before a prescription medicine can be registered in the Australian Register of Therapeutic Goods (ARTG).
-
PageModule 1 is the section that contains administrative information about your electronic Common Technical Document (eCTD) submission specific to Australia.
-
PageHow to withdraw information from your eCTD dossier.
Product changes and variations
Access information to vary products and sponsorship.
-
FormsSponsors can use this form to apply for an additional trade name for a registered prescription medicine, under section 23 of the Therapeutic Goods Act 1989.
-
FormsUse this form for Category 1 and Comparable Overseas Regulator (COR) report-based prescription medicines applications, or variations.
-
User guideThis user guide describes how to change sponsor details in the Product Information (PI) and labels for prescription medicines
-
PageFurther information on next steps in implementing a notifications process for registered medicines
-
PageUpdates to FAQs re the prescription medicines variations e-form
-
GuidanceGuidance on the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines
-
GuidanceGuidance about the types of notifications and variations for biological medicines.
-
GuidanceGuidance about how to make variations to Australian Register of Therapeutic Goods (ARTG) entries for prescription medicines.
-
PageLinks to information on variations to prescription medicines and biologicals.
-
GuidanceGuidance about the types of notifications and variations for chemically derived (non-biological) prescription medicines.
-
PageVary your Australian Register of Therapeutic Goods (ARTG) entry for prescription medicines.
-
PageHow to withdraw information from your eCTD dossier.
Product types