Medicines Repurposing Program

The Medicines Repurposing Program has closed for nominations

Nomination closure allows for current nominations to be assessed by the MRP, prior to cessation of program funding on 30 June 2027.

About the Medicines Repurposing Program

The Medicines Repurposing Program (MRP, the program) aims to improve patient access to medicines in Australia by identifying new indications for existing medicines. It does this by offering fee waivers for regulatory assessment by the Therapeutic Goods Administration (TGA) and fee waivers for consideration of subsidy by the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme (PBS) where possible.

The program was open to nominations from clinicians, health organisations, patient groups, pharmaceutical companies, and researchers.

The program is managed by the TGA, with support from the Technology Assessment and Access Division (TAAD), who manage the PBS.

Under legislation, a medicine cannot be listed on the PBS unless the PBAC makes a recommendation in favour of listing. Information related to the role of PBAC can be found at Pharmaceutical Benefits Scheme (PBS) | Pharmaceutical Benefits Advisory Committee (PBAC) Membership.

Establishment of the program

The program was announced as part of a broader community pharmacy reforms package in the Federal 2023-2024 Budget. The program currently has terminating funding for 4 years, until 30 June 2027.

The repurposing of medicines was included as an action item in the 2020 National Strategic Action Plan for Rare Diseases. Strong interest from patient and clinical groups in the repurposing of medicines was also expressed during the 2021 Parliamentary Inquiry into approval processes for new drugs and novel medical technologies in Australia. This initiative was also mentioned in the Strategic Agreement 2022-2027 with the medicines industry.

During 2021 and 2022, the Department of Health and Aged Care collected stakeholder inputs through workshops, roundtables, and public consultations to inform the Medicines Repurposing Program. Details of the public consultations along with feedback received from stakeholders are available on our website at: Consultation: Repurposing of medicines.

Intent of the program

Medicines are often used in clinical practice for conditions other than those approved by the TGA. This practice is known as ‘off-label’ use. Off-label use is a decision made at the discretion of individual prescribers, sometimes in an ad-hoc manner, and can lead to inequity of access for patients. Bringing ‘off-label’ use under regulatory oversight can expand treatment options and increase prescriber consistency, benefiting more patients.

The concept of repurposing has gained significant attention in recent years. A critical component of this program is the identification of the right candidate medicines, with the appropriate evidence to make new treatment options available. Overseas agencies are engaged in establishing similar programs to support clinicians, researchers, and non-commercial parties in identifying potential new uses for existing medicines. We discuss the approach taken by other regulators and consider applicability in the Australian setting.

For sponsors of generic prescription medicines, lack of commercial value and costs associated with applications often present barriers to applying for approval of a new use. Other parties, such as academic institutions, researchers, and health organisations, may be aware of a medicine’s potential new use and benefit to patients, but may not be adequately resourced to bring these medicines forward for consideration independently.

Identifying potential medicines for repurposing

A dedicated program team oversees the candidate nomination, assessment and selection process, incorporating advice from the Advisory Committee on Medicines (ACM). The ACM provides independent medical and scientific advice to the Minister for Health and the TGA on issues relating to the safety, quality and efficacy of medicines supplied in Australia.

The MRP worked with stakeholders to identify potential candidate medicines and to better understand potential barriers to registration of new indications for existing medications in the Australian market. The MRP continues to seek stakeholder input and feedback to improve and refine the program.

Summary of program outcomes as at August 2026

The MRP opened on 1 March 2024 and closed for nominations on 30 April 2026. A total of 29 candidate medicines have been nominated to the Program, of which 19 have been found unsuitable for selection. 3 candidates have been selected under the program:

• HADLIMA (adalimumab) for the treatment of Behcet’s disease (sponsor: Samsung Bioepis), was selected in December 2024. A regulatory application was submitted in December 2024, with relevant application and evaluation fees waived. HADLIMA was subsequently withdrawn from evaluation by the sponsor in October 2025.
• KINERET (anakinra) for the treatment of Adult Onset Stills Disease (sponsor: Swedish Orphan Biovitrum), was selected in July 2025. A regulatory application was submitted in April 2026, with relevant application and evaluation fees waived.
• PEGASYS (peginterferon alfa-2a) for the treatment of polycythaemia vera and essential thrombocythemia (sponsor: Echo Therapeutics), was selected in February 2026. A regulatory application was submitted in May 2026, with relevant application and evaluation fees waived.

The Program continues to engage with nominators and sponsors regarding existing nominations to the MRP.

Program evaluation

An independent evaluation of the MRP was finalised in June 2026. As part of this process, stakeholders representing government, industry, clinical, research and consumer interests were consulted. The evaluation assessed the success, barriers and opportunities for the future of the Program. Outcomes from the evaluation are now under consideration. 

Program changes

As a result of lessons learned, refinements were made to program eligibility and nomination criteria in early 2025.

In-principle sponsor support

At the time of application, all nominations for the program, require in-principle support from a relevant pharmaceutical sponsor. This addressed complications arising from nominations of different indications with the same active ingredient and  that nominations can be considered by the TGA for evaluation.

Revised nomination process and form

The revised nomination form contained a stronger emphasis on the provision of appropriate clinical and trial evidence to support efficacy requirements for registration of the proposed indication. 

Eligibility criteria 

To be eligible for consideration under the MRP, the nominated candidate medicine was required to:

• Be a prescription medicine that is registered on the Australian Register of Therapeutic Goods (ARTG)
• Propose a new and distinct indication (i.e., use is for a different medical condition or new patient group), and
• Have in-principle support for nomination and consideration by the program from a relevant pharmaceutical sponsor.

Medicines that did not meet the eligibility criteria were not considered for the program.

Evidence requirements

Candidate medicines selected through the program will be offered application and evaluation fee waivers for the registration of an extension of indications (Category 1, Type C) for an existing ARTG registered medicine. This pathway is an existing application pathway and the same evidence requirements and standards apply, as for any other extension of indication application.

Advice from the Advisory Committee on Medicines (ACM)

The program will seek advice from the Advisory Committee on Medicines to confirm the clinical need for the candidate in the Australian context. Feasibility to repurpose a medicine will also be considered, to best realise benefits to patients.

PBS subsidy consideration through PBAC

Candidates selected under the program may also be eligible for fee waivers for Pharmaceutical Benefits Advisory Committee (PBAC) application and evaluation processes. Applications are considered under existing PBAC submission pathways. Further information on eligibility criteria and the application process for consideration of a PBAC fee waiver can be found on the Pharmaceutical Benefits Scheme - Cost Recovery Fees and charges webpage.

Decisions on nominated medicines

Each assessment results in one of the following outcomes:

• Selected for repurposing: The program offers the sponsor of the selected medicine waivers for TGA application and evaluation fees for registration of the extension of indication. Subsequent waivers for evaluation fees for submissions for listing on the PBS may also be available for selected candidates. Selection for repurposing does not guarantee TGA approval of the new use (extension of indication) or PBS listing (subsidy). Applications will be evaluated as per standard pathways by the TGA and PBAC.
• Unsuitable for repurposing: These applications are assessed as unsuitable, due to insufficient evidence to demonstrate efficacy for the proposed new use, or a lack of sponsor interest. In the event of any new development or significant change in either aspect, the medicine could be re-nominated with the new evidence prior to the closure of nominations on 30 April 2026. However, re-nomination did not guarantee any specific outcome or future selection for repurposing.

As the selection process involves multiple processes with variable timeframes, an overall timeframe, from nomination to selection, is unable to be provided.

Contact

For all enquiries please email mrp@health.gov.au.