Testing of biological medicines

We will not be routinely performing batch release testing on newly registered biological medicines (excluding vaccines). Newly registered biological medicines will no longer have conditions of registration requiring the supply of samples to us for testing for the initial batches applied to them. These changes have already been put in place for currently registered biological medicines.

Our laboratories are still testing the quality of products on the Australian market. This will be through spot checks on the quality of biological medicines being supplied. Periodically we will request that sponsors supply samples for testing in these product quality surveys.

Batch release of vaccines will continue unchanged, and sponsors will still be required to submit batch release documentation and samples before supplying a batch of vaccine in Australia. Additional information is available at our Batch release assessment of COVID-19 vaccines page.

More information on the way we test products and testing results is available at our TGA Laboratories: What we test and how to access the results page.

If you have any questions, please contact us at TGA.Laboratories@health.gov.au.