Reforms will tighten regulation of CAR T-cell therapies in Australia
Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), has announced it will reform the way autologous human cell and tissue products are regulated.
The changes will mean that more products will be subject to regulation as biologicals, and the existing rules will be strengthened.
The level of regulation will be decided by the risk posed to patient safety. In addition, direct advertising to consumers will be prohibited.
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