NEWS
New UDI Requirements for Medical Devices
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. ...more
Therapeutic Goods Administration
July 06, 2026•5 min read
The TGA Compliance Principles
The TGA compliance principles are grounded in scientific rigor, risk-based thinking, and lifecycle control of therapeutic goods. ...more
Therapeutic Goods Administration
May 13, 2026•6 min read
Common Regulatory Challenges for Therapeutic Goods Manufacturers
Therapeutic goods manufacturers face a complex and evolving regulatory landscape, with challenges spanning quality management, data integrity, validation, and supply chain oversight. While these chall... ...more
Therapeutic Goods Administration
April 22, 2026•6 min read
Proposed regulatory changes to medicine labelling requirements in Australia
The proposed changes to medicine labelling requirements in Australia represent a significant regulatory update aimed at improving safety, clarity, and consistency across therapeutic goods. ...more
Therapeutic Goods Administration
April 08, 2026•5 min read
Educate To Empower
The TGA’s "Educate to Empower" initiative, as outlined in the 2026–2027 Compliance Principles, provides a robust framework for supporting therapeutic goods organisations in regulatory compliance. ...more
Therapeutic Goods Administration ,Quality Training
February 23, 2026•4 min read
TGA Compliance Principles 2026 and 2027
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. ...more
Therapeutic Goods Administration ,Compliance
February 22, 2026•5 min read
