The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods. Products must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. RBridge Lifesciences provides expert support for market assessment, dossier preparation, and all stages of TGA registration.
What We Offer
- Market Assessment and Regulatory Pathway Identification
- Dossier Preparation and Submission
- Query Resolution and Registration Holder Services
- Gap Assessment
- Agency Liaisoning
About TGA Registration
- TGA evaluates prescription medicines, OTC products, biologicals, and complementary medicines
- Submissions follow CTD format; ARTG inclusion is mandatory before supply in Australia
- TGA has mutual recognition arrangements with several international regulators
- Post-market obligations include periodic safety updates and variation submissions