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 …
It has been a big year for industry as organisations scramble to be in full compliance with PIC/S PE009-13. With the due date on January 1st 2019, this deadline is coming sooner than many …
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 …
On October 31, the ODC released an online smart form as well as “flat” paper forms to apply for a cultivation, production or research medicinal cannabis licence. This online form can also be used …
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 …
The recent scheduling changes to medicinal cannabis, which includes cannabidiol (CBD) and tetrahydrocannabinols (THC), moving it from Schedule 9 (prohibited substance) to Schedule 8 (controlled substance) coupled with the rapidly evolving legislative change around …
Continuous Product Quality Reviews and FDA quality metrics
Are annual PQRs an old school way of thinking?
A few years ago I was working on a non-pharma, large scale ERP project for a multi-national. During the …
Medical Device Data Systems
On the 9th February the FDA released the Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (MDDS),’ Guidance for Industry and Food and Drug Administration Staff. …
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, …
Purpose
This White Paper on how to “How to list or register a medicine in Australia” is written to assist those interested in the process for approval to supply TGA regulated therapeutic products in Australia.
Audience
This White …
