TGA

medicinal cannabis products

TGA GMP Manufacturing licence for Medicinal Cannabis

This blog is intended as a current guide how to set about applying for a TGA GMP Manufacturing license for Medicinal Cannabis.
Process for applying for a TGA GMP Manufacturing Licence
Two Manufacturing Licences may be …

Updates to TGA fees and charges

Every year the TGA undertakes a comprehensive targeted consultation by engaging with peak therapeutic industry bodies in regard to the fees and charges proposal for the upcoming financial year.

The TGA is required to recover …

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, …