FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

TGA Tightens Its Regulations on Stem Cell Treatments

July 17, 2019
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Australia’s Therapeutic Goods Administration (TGA) has strengthened its regulation of stem cell treatments to protect consumers from shoddy products.

The agency said it has expanded its oversight in response to “concerns about some providers offering unproven and harmful treatments.”

The new regulations require all providers of cell and tissue products operating outside of hospitals to meet the agency’s safety, quality and effectiveness requirements, with possible criminal charges for those who fail to comply.

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