Enabling Australia’s onshore mRNA manufacturing capability: approach to market
13 July 2021: Updated information about response requirements for this approach to market
We’ve received a number of enquiries about this approach to market process. Responses to questions and points of clarification are available in our questions and answers documents:
- Approach to market questions and answers 13 July 2021 [154KB PDF] [69KB DOCX]
- Approach to market questions and answers 30 June 2021 [382KB PDF] [80KB DOCX]
- Approach to market questions and answers 21 May 2021 [334KB PDF] [74KB DOCX]
We held an online industry briefing session on Thursday 27 May, at 2.00pm. This briefing provided an opportunity to ask questions that can help you prepare your proposal.
Throughout this approach to market, we strongly advise that you regularly check this page. We will post any updates, notices or other useful information on this page only.
Building on the success of COVID-19 mRNA vaccines, the Australian Government recognises that mRNA technology is part of the next generation in advanced health care.
Onshore production of mRNA vaccines will strengthen our capacity against future pandemics and other diseases. But this is a new challenge the entire world is grappling with, and we recognise it will take time to develop.
The Medical Products Road Map identifies mRNA vaccine growth opportunities. The road map unlocks opportunities in the medical products sector and informs policy and co-investment decisions. This includes decisions made under the Modern Manufacturing Initiative – the centrepiece of Australia’s Modern Manufacturing Strategy.
On 21 May 2021, the government opened this approach to market. It enables manufacturers who can provide mRNA manufacturing capability in Australia to plan a partnership approach with the government to bring forward this capability.
How to make a proposal and what your proposal needs to address
The Approach to Market document explains in detail what your proposal needs to address and how you can lodge it:
Note: Version 1.1 is correct at 24 May 2021 and was updated to correct minor formatting changes to support accessibility and readability.
To summarise, the government is seeking information in the form of fully costed proposals to establish an onshore, population-scale mRNA manufacturing capability, to be fully operational with requisite regulatory approvals/licences within a timeframe of between 12 months (or earlier, if possible) and no later than 3 years from finalisation of an agreement with the government. In doing so, the government seeks to meet the following objectives:
- To ensure priority access to, and reliable delivery of, safe and effective prospective mRNA vaccines and any mRNA therapeutics to the Australian population as soon as they are available, on an ongoing basis.
- To provide security of vaccine supply to address pandemics and other health emergencies into the future.
- To strengthen Australia’s biopharmaceuticals sector, including through enabling potential translation and commercialisation paths for Australian-based research and development.
This approach to market is open for 8 weeks: 21 May to 16 July 2021.
Proposals must be lodged by 2.00pm, Canberra time, on Friday 16 July 2021.