Therapeutic Goods Administration (TGA)
Assesses the quality, safety and efficacy of medicines and enters them on the Australian Register of Therapeutic Goods, which a medicine must hold before it can be supplied or subsidised.
Responsibilities
- Evaluate applications for registration on the ARTG
- Operate provisional and priority approval pathways
- Monitor safety post-market
Operates under
- Therapeutic Goods Act 1989 (Cth)
Registration and subsidy are two separate decisions by two separate bodies about two different questions. The TGA asks whether a medicine is safe and works. The PBAC asks whether the Commonwealth should pay for it, and at what price.
That separation is correct and this database does not question it. A medicine that works may still not be worth what its sponsor is asking, and merging the two decisions would put a cost-effectiveness judgement inside a safety regulator.
The sequencing has already been reformed in the way this site usually recommends. Under the TGA and PBAC parallel process, registration and reimbursement evaluation can run concurrently for eligible submissions rather than end to end. A PBS listing still cannot take effect before the medicine is on the ARTG — a genuine dependency, since the Commonwealth should not subsidise a medicine that may not be approved — but the assessment work overlaps.
It is worth recording an example of a step already parallelised, because most of this database consists of arguing that steps should be. Here somebody already did it, and the remaining delay in getting a medicine listed sits after both assessments are finished.
Where this body appears in a process
Every point at which Therapeutic Goods Administration can hold something up, and why.
| Process | Step | Why it waits | Clock | Typical |
|---|---|---|---|---|
| A new medicine is listed on the Pharmaceutical Benefits Scheme | TGA evaluation for registration assessment | assessment | — | 330 |
