TGA submissions that use your existing approvals intelligently
Part of our Regulatory Affairs services, from a clinician led team serving India, MENA, Europe, and global markets.
Australia's Therapeutic Goods Administration (TGA) regulates medicines and medical devices through inclusion on the Australian Register of Therapeutic Goods (ARTG), and it offers something valuable to companies that already hold approvals elsewhere: formal pathways that use assessments from comparable overseas regulators to streamline Australian review. Used well, an existing US FDA or EMA approval substantially reduces the Australian evidence burden; used naively, sponsors discover late that the overseas package does not map cleanly onto Australian requirements.
EvySaif prepares TGA submissions for medicines and devices, structuring the dossier around what your existing approvals can carry and what Australia asks for beyond them. Australia requires a local sponsor to hold the ARTG entry, and as with our Gulf work, we help you set up that relationship with the regulatory responsibilities made explicit.
What the Australian route involves
- Medicines. Prescription medicines follow CTD based registration, with pathways that draw on comparable overseas regulator reports where an accepted authority has already assessed the product, shortening evaluation without removing Australian scrutiny of the key questions.
- Medical devices. ARTG inclusion is conformity based, and the TGA accepts specified overseas conformity assessment evidence, including European certification, as support for most device classes, with Australian specific requirements layered on top.
- Local sponsor. Every ARTG entry is held by an Australian sponsor who carries ongoing regulatory obligations, from vigilance reporting to responding to the TGA, so the sponsor arrangement is a regulatory decision, not only a commercial one.
- Post-market obligations. Adverse event reporting, annual charges, and change management continue for the life of the ARTG entry, and we build that maintenance picture into the plan rather than leaving it to be discovered.
Where EvySaif fits
We assess which pathway your evidence supports, prepare or adapt the dossier, draft responses to TGA questions, and coordinate the documentation between your overseas approvals and the Australian submission. TGA planning slots into a global sequence through our regulatory strategy consulting, alongside the market pages for the US FDA and EMA approvals that most often serve as the Australian reference.
Frequently asked questions
Can our FDA or EMA approval speed up TGA registration?
Often, yes. The TGA operates pathways that use assessment reports from comparable overseas regulators for medicines, and accepts specified overseas conformity assessment evidence for devices, which reduces duplication while retaining Australian review of the essentials.
Do we need an Australian sponsor?
Yes. The ARTG entry must be held by an Australian sponsor who carries the ongoing obligations, and foreign manufacturers without a local entity appoint one; the agreement should allocate regulatory responsibilities clearly.
Do you handle devices as well as medicines?
Yes. We support ARTG inclusion for medical devices and IVDs, including mapping European technical documentation onto Australian requirements, alongside prescription medicine registrations.