Does imported IVIg meet the same safety standards as domestic IVIg?
Yes. All blood, blood components and plasma derivatives supplied in Australia are regulated under the Therapeutics Goods Act 1989 by the Therapeutic Goods Administration (TGA). The TGA is responsible for enforcing standards within the blood sector to ensure blood products meet appropriate safety, quality and efficacy requirements. It also registers individual products for specific uses. The TGA undertakes a comprehensive assessment of the safety, quality and efficacy of all domestic and imported plasma products before they can be registered on the Australian Register of Therapeutic Goods and approved for supply in the Australian market. The TGA licences (manufacturers in Australia) or certifies (manufacturers located overseas) the facilities where plasma products are manufactured against standards of Good Manufacturing Practice (GMP). Audits are conducted to ensure ongoing compliance with GMP.
