Overseas companies seeking to supply therapeutic goods in Australia face a requirement that often catches them off guard: they cannot register a product on the Australian Register of Therapeutic Goods (ARTG) themselves. The law requires an Australian sponsor — a person or business residing or incorporated in Australia — to take legal responsibility for the product.
This is not a formality. The sponsor's obligations are substantial. They must ensure the product meets ongoing TGA requirements, manage post-market reporting, respond to TGA inquiries, and maintain the ARTG entry throughout the product's commercial life.
What the sponsor role involves
The sponsor is the TGA's primary point of contact for the product. Practically, this means:
- Submitting the initial application and managing the evaluation process - Keeping product information and labelling current - Reporting adverse events and product defects - Notifying the TGA of changes to the product or its manufacturing - Maintaining records in line with TGA requirements
For overseas companies, this usually means either establishing an Australian entity or engaging a third-party sponsor — a regulatory consultant or service provider who takes on the role contractually.
Choosing the right sponsor
Not all sponsors are equal. A sponsor who lacks regulatory depth may miss deadlines, mishandle queries, or fail to maintain the ARTG entry correctly — which can result in the product being removed from the register.
When evaluating a sponsor, look for direct experience with TGA submissions in your product category, familiarity with the evidence requirements for your registration pathway, ability to respond to TGA questions in a timely and technically credible way, and systems for ongoing pharmacovigilance and post-market reporting.
How TPC can help
Trans-Pacific Compliance offers Australian sponsor services for overseas pharmaceutical and device companies. Our team manages the complete TGA relationship — from initial strategy through submission, evaluation, and ongoing post-market obligations.
If you are planning to enter the Australian market, contact us to discuss your product and the right pathway forward.