Home » TGA Broadens Definition for Regulated Biologics
TGA Broadens Definition for Regulated Biologics
Drugs Regulatory Affairs
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.