Physical samples for batch release not required: a reminder for sponsors of biosimilars and biological medicines

Source: Australian Department of Health

The Therapeutic Goods Administration (TGA) is reminding sponsors of biological medicines and biosimilars that physical samples are not required for batch release until further notice.

This reminder follows on from email communication from the TGA to sponsors, informing them of this change, which will be reassessed in June 2020.

This change in process is to facilitate batch release of biological medicines during the COVID-19 pandemic.

Sponsors should still supply protocols for products on batch release. Batch release will be performed via an assessment of the protocols only, with the aim of reducing turnaround times during the pandemic.

This only applies to biological medicines and biosimilars that are currently on batch release. The following remain unaffected by the decision:

  • Older products not on batch release
  • Pre-market evaluations
  • Post-market monitoring of biological medicines and biosimilars, including periodic laboratory testing.

The TGA’s laboratories are still testing the quality of products on the Australian market.

As usual, if there are concerns noted with the quality of a product through protocol assessment, the TGA Laboratories will contact the relevant sponsor to discuss the concern.

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