What is Pre-use Post Sterilisation Integrity Testing (PUPSIT)?
PUPSIT stands for pre-use post sterilisation integrity testing. PUPSIT is performed once your sterilising filter is installed to ensure that the sterilisation and installation process has not …
With the legalisation of cultivation and export of medicinal cannabis products within Australia, many growers and companies producing medicinal cannabis products have set their interest in exporting their excess products to other parts of …
SaMD: A need for Regulatory Reform in Australia
In February 2019, the TGA issued a consultation for feedback from industry on how Software as a Medical Device (SaMD) is regulated in Australia. Currently, SaMD is …
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: This page provides an overview of GMP & Engineering Forum and manufacturing industry networking events. Click on the links below for information on the upcoming National GMP Forum and other industry-leading …
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 …
