Australia

Why Australia

Australia has become an international leader in pharmaceutical research and development.

Skilled workforce and highly innovative medical ecosystem

Australia has a highly skilled and educated workforce, providing a pool of talented individuals for the pharmaceutical industry. Australia is home to over 1,200 pharmaceutical and medical technology companies, 55 world-class medical research institutes and 40 universities that focus on clinical research. The Australian clinical trial industry has seen substantial growth and there are more than 50 clinical trial networks in the country. The Australian government is extremely focused on promoting and growing the pharmaceutical and biologics sectors through significant tax incentives and R&D grants.  

Strong regulatory frameworks and alignment with international regulatory agencies

Australia has a strong regulatory framework for pharmaceutical manufacturing, ensuring high-quality production standards. The TGA closely aligns its regulatory approach for pharmaceutical products with those of comparable international regulatory counterparties including the United States’ FDA, European Union’s EMA, and the United Kingdom’s MHRA. Australia’s TGA has a strong working relationship with all majority regulatory bodies and is an internationally recognized and respected regulatory authority. The TGA and FDA have a specific cooperative agreement regarding the exchange of information on GMP inspections of pharmaceutical facilities. The TGA also has a mutual recognition agreement in place with the EMA for GMP compliance.

Strategic location

Our expert staff is highly experienced interfacing with clients around the globe in multiple time zones. We can provide a next day answer to any question or problem that comes up during the development process. NovaCina is 12 hours ahead, so you are never behind (USA East Coast).

Perth is located in an exciting time zone in a region full of growth opportunities within South East Asia – with almost full overlap with China, Japan and India. There is a healthy half day overlap with Europe as well as the beginning and end of each day with USA for those next day answers.

There are significant transport hubs close by with Singapore and Middle East, with direct access Europe from Perth and to US from the East Coast of Australia.

Australia Incentives

Australia offers cost-efficient drug development, with R&D up to 60% less expensive than in the US. R&D tax incentives include a refundable tax offset of up to 43.5% for eligible entities, with no ceiling on growth in R&D expenditure. Access to funding through various government and private sector programs, including the Biomedical Translation Fund and MTPConnect.

Clinical trials in Australia are faster due to streamlined ethics committee assessments and no IND requirement. Australia has compatible quality and regulatory requirements, strong IP protection with up to five years of patent term extensions and data exclusivity. The Australian pharma sector is top-ranked globally, with a history of significant contributions to pharma development. Government support and tax incentives continue to drive growth in the pharma industry.