CDMO Regulatory & Compliance: TGA (Australia)

The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority responsible for ensuring the quality, safety, and efficacy of medicines, medical devices, and biological products. The TGA is a division of the Australian Department of Health and Aged Care and is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), aligning its Good Manufacturing Practice (GMP) standards with international best practices.