Closing date for nominations
The program will close for nominations on 30 April 2026. The closing date allows for incoming nominations to be assessed by the MRP, prior to cessation of program funding on 30 June 2027.
Summary of program outcomes as at February 2026
The Medicines Repurposing Program (MRP, the program) opened on 1 March 2024. A total of 25 candidate medicines have been nominated to the Program to date, of which 20 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 and accepted for evaluation in February 2025. HADLIMA was withdrawn from evaluation by the sponsor in October 2025.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 is expected in 2026.
- PEGASYS (peginterferon alfa-2a) for the treatment of polycythaemia vera and essential thrombocythemia (sponsor: Echo Therapeutics), was selected in February 2026.
The Program continues to meet with nominators and sponsors regarding potential nominations to the MRP.
Program evaluation
An Independent Evaluation of the MRP is underway and will consider the success, barriers and opportunities for the future of the Program. Options for a future program post 30 June 2027, will be further canvassed through planned public consultation in mid-2026.
Issues encountered and lessons learned
A few common issues were identified in early nominations to the Program.
Sponsor engagement
While nominators were encouraged to contact pharmaceutical sponsors prior to proposing candidates for the program, it was not a mandatory. A candidate medicine is unable to progress through the program without a willing sponsor application, to enable the regulatory fee waivers to be applied. Lack of sponsor engagement was a key reason candidate medicines were not able to progress.
Nomination by active ingredient
The program received several nominations (different indications) for the same active ingredient. This presented challenges with regards to assessment and discussions with sponsors.
Insufficient supporting evidence
Evidence of established clinical use in Australia was a mandatory requirement. The inclusion of the use in clinical treatment guidelines and support from clinician groups, were both considered as a supportive evidence base. This enabled an initial review by the program team to determine feasibility to progress through existing TGA registration pathways.
The level of supporting evidence provided by some nominations was insufficient to enable proper consideration of feasibility for the proposed indication. Where clinical guidelines were identified, many of the applications were not sufficiently underpinned by the clinical standard of evidence needed to support registration of the proposed indication.
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 or an indication of interest from a relevant pharmaceutical sponsor. This addresses complications arising from nominations of different indications with the same active ingredient and ensures that nominations can be considered by the TGA for evaluation.
Relevant pharmaceutical sponsors can be identified by searching the Australian Register of Therapeutic Goods.
Revised nomination process and form
The revised nomination form contains a stronger emphasis on the provision of appropriate clinical and trial evidence to support efficacy requirements for registration of the proposed indication.
The nomination form will be available on request and provided after initial eligibility requirements, including in-principle support from a pharmaceutical sponsor, have been confirmed. The program team welcomes meetings to discuss eligibility requirements by potential nominators.
The program remains open for nominations and applications will be assessed and considered on a rolling basis and as they are received.
Contact
For all enquiries and to discuss program eligibility requirements please email mrp@health.gov.au.