Sometimes when medicines are in long-term shortage there is still a clinical need for the medicines in Australia.
We welcome applications to register new generics of medicines included in the Australian Register of Therapeutic Goods (ARTG) that are in long-term shortage. By supporting continued availability of medicines, you are helping to achieve better health outcomes for patients affected by long-term shortages. This is an opportunity for corporate philanthropic contribution and could also be a potential commercial opportunity.
This page assists sponsors by collating useful resources to support registration of medicines in long-term shortage and access to further advice.
Identifying medicines in long-term shortage
We have selected a list of medicines that have a history of shortage, are clinically important and impact on public health.
You can also download a .csv file from our medicine shortage reports database archive to identify other molecules that have been in repeated or long-term shortage.
Registration of generic medicines to address long-term shortage
We welcome applications to register medicines in long‑term shortage to help patients with continued and more reliable access. Medicines in long‑term shortage include medicines that are discontinued and no longer supplied in Australia.
If your registration application relies on data previously submitted to us by the sponsor of the registered Australian reference product, a patent certificate must be provided to us. Where a prescription medicine has been included in the ARTG for less than five years, an application for a generic medicine will require its own clinical data and cannot rely upon the clinical data relating to the ARTG-included medicine.
All prescription medicine applications are assessed against the same high safety, efficacy and quality standards required for use in Australia. The following information may assist you with lodging a registration application.
Resources for prescription medicine registration
- Information on how to apply for registration of a new generic prescription medicine is available on our Prescription medicines registration process page. Comprehensive information on registration is included in the Australian Regulatory Guidelines for Prescription Medicines.
- If you are new to the process, SME Assist provides a dedicated service that offers help to those unfamiliar with therapeutic goods regulation.
- The Common Technical Document (CTD) dossier document matrix provides information on the supporting information required for different application types.
- For more information refer to requirements for an effective application.
Applications to register prescription medicines in long‑term shortage
We may prioritise starting the evaluation of a registration application to mitigate or reduce the risk of medicine shortage, depending on the public health interest. Existing legislated timeframes for evaluation continue to apply to all registration applications.
- Advise us in your application cover letter if your registration application is intended to manage or prevent a shortage, or the medicine is on our list of medicines in long term shortage.
- The TGA will accept applications for registration of the same molecule from multiple sponsors in parallel.
- The TGA will consider whether to prioritise starting the evaluation of your registration application once it is received. Identified medicines will be prioritised for evaluation. Notification letters will be provided, as determined by our application processes.
- Ask for prioritisation of your Good Manufacturing Practice (GMP) clearance or license application if the medicine that is subject of your application is included on our list or has a shortage notification on our database. We need the medicine shortage notification details or reference to our list of medicines in long-term shortage to help us assess and support the prioritisation of your GMP application. To find out if a shortage has been notified to the TGA, you can search our medicine shortage reports database.
Comparable Overseas Regulator (COR) applications
If a medicine in long-term shortage is supplied under section 19A of the Therapeutic Goods Act 1989, then, in most cases, the product has already received market authorisation by a comparable overseas regulator, and a comparable overseas regulator (COR) application may be a suitable registration pathway. The COR report-based process is associated with a shortened evaluation and decision timeframe.
Use the COR application checklist to determine if your registration application is suitable for a COR-A or COR-B approach.
There are two types of COR applications.
- Consider the COR approach A (COR-A) if the full marketing approval of the medicine is no older than one year. The evaluation and decision time frame for COR-A applications is 120 working days. To meet this significantly shortened timeframe, the application must meet specific requirements.
- The COR approach B (COR-B) has a 175 working day evaluation and decision timeframe, allowing for TGA evaluation of certain data, in addition to the label, Product Information (PI) and Risk Management Plan (RMP).
More information about the COR application pathways is available at:
- Comparable overseas regulators (CORs) for prescription medicines
- Comparable overseas regulators (CORs): submission requirements.
General advice about quality requirements
When considering a registration application for a new generic medicine, you may have questions about the quality requirements for your application. We have collated resources that provide general advice on quality requirements for generic medicines.
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Information on choosing a reference product to show bioequivalence is available in our Guidance on bioequivalence for generic medicines.
- The same guidance sets out the conditions and requirements for use of an overseas reference product in a bioequivalence study used to support a generic medicine application.
- Seek early scientific advice if you need our guidance on a generic medicine biowaiver justification for an oral dosage form. Please note a fee applies. We can give pre-submission advice on:
- Biopharmaceutic Classification System (BCS)-based biowaiver justifications
- Additional strength biowaiver justifications
- Justification for use of an overseas reference product in a bioequivalence study.
- For new generic medicines, establishing bioequivalence with the Australian reference product allows bridging to the nonclinical and clinical studies. If your supporting evidence does not meet the requirements for registration because the reference medicine was registered a long time ago, you may need to provide bridging studies or an appropriate justification to support your application.
Further information
If you still have questions about the quality requirements for registering a generic medicine that may help mitigate a long-term shortage, contact us at:
- pcsinbox@health.gov.au (generic medicines)
We assess complex enquiries on a case-by-case basis. Please provide details of the drug substance, dosage form and reference product in your enquiry.
Biological medicines registration
For information on biological medicine registration applications please review our guidance at:
For questions relating to biological medicines or biosimilars, contact us at:
- info@tga.gov.au (biological medicines including biosimilar)