TGA proposed changes to the biologics regulatory framework

Posted 6 years ago

The Therapeautic Goods Administration (TGA) has published guidance on the upcoming changes to the regulation of autologous human cells and tissues (HCT) products. This is to assist in interpretation of new requirements that are likely to come in to effect from 1 July 2018 (subject to Government approval).

These changes will aim to improve patient protection from providers of unproven therapies and ensure patients have access to safe and effective new therapies. Changes will also include a prohibition on advertising autologous HCT products to patients, and a requirement to report adverse events.

For more information, visit the TGA website.