After a lengthy consultation process, the TGA has opted for ‘light touch’ regulation of faecal microbiota transplant (FMT) products if they are manufactured and used in a hospital. Under a new regulatory model that will come into effect from 1 January 2020, the TGA will waive TGA data assessment and Good Manufacturing Practice (GMP) requirements ...
Hospital-based FMT gets minimal regulation under TGA’s chosen model
By Michael Woodhead
26 Sep 2019