TGA squeeze on stem cell therapies
The TGA will move to close the regulatory loophole that allows private clinics to provide pricey, unproven stem cell procedures.
Autologous stem cell treatments are not regulated by the TGA because a patient’s own cells are not classed as a therapeutic agent.
For the past two years, the regulator has been consulting on five regulatory options, ranging from minimal to stringent.
It has now announced that it will impose a sliding scale of more stringent controls in line with other countries.
Regulations will apply for autologous cell and