Recognising that some organisations may require additional time to complete implementation, the TGA has introduced a streamlined UDI Consent to Supply process commencing on 1 July 2026.
The TGA compliance principles are grounded in scientific rigor, risk-based thinking, and lifecycle control of therapeutic goods.
Therapeutic goods manufacturers face a complex and evolving regulatory landscape, with challenges spanning quality management, data integrity, validation, and supply chain oversight. While these challenges are diverse, they share a common underlying cause: insufficient visibility and control at the system level.
The TGA Compliance Principles 2026 and 2027 provide a structured, risk-based framework for monitoring, enforcing, and supporting compliance with the Therapeutic Goods Act 1989.