What Regulation of Biologicals under the Therapeutic Goods Administration (TGA) - Classification, Manufacturing, and Clinical Evidence Requirements for Class 1-4 Biologicals requires
The TGA Biologicals Framework requires all biologicals (Class 1-4) to be classified based on risk, manufactured under Good Manufacturing Practice (GMP), supported by clinical evidence appropriate to class, and included in the Australian Register of Therapeutic Goods (ARTG) prior to supply. Applies to sponsors and manufacturers of human biologicals under the Therapeutic Goods Act 1989, Section 20 and Biologicals Regulatory Framework guidance.
Pillar: Biotech & Genomics · Authority: Therapeutic Goods Administration (TGA), Department of Health and Aged Care, Australian Government · Version: 1.0.0 · Last updated:
Primary source: https://www.tga.gov.au/products/biologicals/regulation-biologicals
SHA-256 integrity: 6ea0dc3614940bab0d9a9deba26f2027313c80b1e762e290cfba55ded4385409
Primary Citations — 5 traced to source
- Therapeutic Goods Act 1989, Section 20 - Inclusion in the Australian Register of Therapeutic Goods (ARTG)
- TGA Biologicals Regulatory Framework - Section 3: Classification of Biologicals into Risk-Based Classes (Class 1-4)
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