Search


TGA Guidance: GMP Update for Medicinal Products in Australia: Transitioning to PIC/S Guide PE009-17
Good Manufacturing Practice (GMP) serves as the backbone of pharmaceutical quality assurance. It ensures that medicinal products are...
Sharan Murugan
Aug 282 min read
Â
Â


Australia TGA's Guidance: Regulatory Landscape for Personalised Medical Devices and Companion Diagnostics
As the healthcare industry continues to evolve, the integration of personalised medical devices and companion diagnostics has become...
Sharan Murugan
May 243 min read
Â
Â
Australia's TGA Guidance Blog: Labelling and Presentation Requirements for Listed Medicines
On 9 April 2025, the Therapeutic Goods Administration (TGA) released updated guidance titled “ Understanding Labelling and Presentation...
Sharan Murugan
Apr 233 min read
Â
Â


Australia (TGA) Med Dev User Guide: Completing an Application for Consent to Import, Supply, or Export a Medical Device That Does Not Meet the Essential Principles
The Therapeutic Goods Administration (TGA)Â has released Version 3.0Â of its user guide, effective from March 2025, " Completing an...
Sharan Murugan
Mar 212 min read
Â
Â


TGA Guidance: Consent for Non-Compliant Medical Devices that do not meet the Essential Principles
The Therapeutic Goods Administration (TGA)Â has released updated guidance in "Completing an application for consent to import, supply, or...
Sharan Murugan
Mar 112 min read
Â
Â
