The Access Consortium is a coalition of like-minded regulatory authorities working together to promote greater regulatory collaboration and alignment of regulatory requirements. Learn how the ACCESS Consortium can streamline medicine approvals in Australia and partner countries, accelerating access to new therapies.
Australia as an Early Entry Market for Medicines
Australia is an increasingly attractive early entry market for global pharmaceutical and biotechnology companies. Over the past decade, reforms and government incentives have aimed to improve patient access to therapeutic products while streamlining regulatory processes.
Historically, medicines in Australia were registered through a standard (national) pathway. However, major reforms have introduced new options including reliance and work-sharing pathways, as well as provisional and priority reviews— designed to accelerate approvals and expand access. Since the pandemic, over one quarter of applications have utilised these non-standard pathways.
Welcome to the ACCESS Consortium
A key international work-sharing initiative is the ACCESS Consortium1, which facilitates the registration of medicines containing new active substances, generic and biosimilar medicines across Australia, Canada, Singapore, Switzerland, and the UK. In the 2023–24 financial year, nearly 25% of new medicines approved in Australia—9 of 37—used the ACCESS pathway2.
The TGA anticipates continued growth in international collaboration and further integration of frameworks across ACCESS agencies. Recent developments include harmonised priority review determinations and joint pre-submission (pipeline) meetings.
ACCESS Consortium members
How the ACCESS Consortium Process Works
Applicants:
- Select participating countries
- Engage early with regulators to discuss the product/application, submission timelines, and priority status
- Submit a formal Expression of Interest to formalise the arrangements
To initiate review:
- Submit identical technical dossiers (CTD Modules 2–5) to all selected agencies simultaneously
- Administrative and labelling sections may be country-specific
During evaluation:
- Agencies coordinate reviews and share evaluation reports and queries
- After the work-sharing phase concludes, each agency proceeds with their national phase, whereas labelling and other, country specific details are discussed and the final decision on approval is made
Benefits of the ACCESS Pathway
Although overall timelines are similar to a standard, national registration process, securing a priority designation status in each country can significantly shorten review periods.
When well-planned and executed, work-sharing can lead to near-simultaneous approvals.
Benefits include:
- Efficient use of resources
- Harmonised dossiers
- Fewer duplicate information requests
As these pathways evolve, improvements are expected in milestone adherence, alignment on submission dates in all countries, and resolving any issues arising from competing registration pathways in the different countries.
Strategic Considerations for Global Market Entry
Understanding the unique, country specific features of the medicine regulations is critical to optimising global development and commercialisation strategies. Companies are encouraged to involve Australia early in global strategies, to accommodate pre-submission activities, such as GMP clearances and priority or orphan designation applications.
A well-informed regulatory strategy enables timely, cost-effective navigation of these pathways—without compromising safety, quality, or efficacy. Including Australia early in global strategy planning can secure a strategic registration in the Asia-Pacific region, complementing approvals in major markets like the US and EU and facilitating broader regional access.
At The Adjutor Group, we recognise the importance of not just understanding all of the available medicine registration pathways, but also leveraging our expertise to assist you in developing and executing your global strategy. Whether you are seeking to register a new medicine in Australia or expand into international markets, our team is equipped to guide you through every step of the process.
Further reading:
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How to Register a Medicine in Australia
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Moderna mRNA COVID-19 Vaccine Approved in Australia
The vaccine was approved in just 23 days via the ACCESS Consortium track due to a heroic effort by the TGA, Moderna and the The Adjutor Group. […]
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ACCESS Consortium: Streamlined Evaluation Process for Medicines in Multiple Countries.
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