TGA Broadens Definition for Regulated Biologics

Australia’s Therapeutic Goods Administration released proposed amendments to its biologics regulations set to take effect on July 1.

Under the proposal, a substance will be regulated as a biological rather than a blood component if it is subject to processing involving “more than minimal manipulation.” The broader definition incorporates conditioned serum and adipose-derived cell extract, which had previously been excluded from regulation.

The regulation is similar to European Medicines Agency’s approach for stem cell products.