TGA

Sue MacLeman MTPConnect

Australian-first Manufacturing and Hands-on Training Facility

Australian-first manufacturing and hands on training facility to produce medical products for early stage human clinical trials receives funding from MTPConnect’s Project Fund Program
PharmOut is proud to partner with these prestigious Australian organisations and …

TGA – medicinal cannabis GMP compliance guideline

Today the TGA just released a new medicinal cannabis GMP compliance guide titled “Guidance on GMP compliance for the manufacture of medicinal cannabis for supply under ‘approved access’ provisions”.

Not sure there would be any experienced …

TGA issues new Australian Complementary Medicine Guidelines

Previously we wrote about the TGA planning to revise the complementary medicine guidelines. On the 13 October 2016 the Australian TGA released the sixth version of the Australian regulatory guidelines for complementary medicines ARGCM, Version 6.0, October …

TGA medical devices

The Medical Device Single Audit Program

In October 2013, the Therapeutic Goods Administration (TGA) announced the launch of the Medical Device Single Audit Program (MDSAP) pilot from January 2014, together with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, …