Counterfeit medicines — fake drugs and falsified medicines — are endangering lives.
How large is the problem of substandard medications and falsified pharmaceuticals? What are the global statistics of counterfeit medications entering countries across …
What is the current number of medicinal cannabis prescriptions in Australia so far?
The number of Medicinal Cannabis prescriptions in Australia is expected to reach 10,000 prescriptions by July 2019.
This is a significant increase from …
Future of Pharma: The 9th Annual National GMP Forum, featuring ‘future of pharma’ innovation discussions and unique Masterclass options for Day 3, is accepting registrations. Registrations close in just a few weeks time, so …
There is widespread demand for access to medicinal cannabis products by patients. Yet very few Australian doctors currently prescribe cannabinoid-derived medications. Will emerging clinical trial evidence reduce the reluctance of GPs to prescribe these …
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 (abbreviated as “CBD”) and tetrahydrocannabinols (“THC”), moving it from Schedule 9 (prohibited substance) to Schedule 8 (controlled substance). This change, coupled with the rapidly …
