TGA

pupsit

Pre-use Post Sterilisation Integrity Testing – PUPSIT

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 …

exporting-medicinal-cannabis

Exporting Medicinal Cannabis from Australia to Germany

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 …

software-as-a-medical-device

Software as a Medical Device (SaMD)

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 …

fake cannabis medications in australia

Counterfeit Medications | Global Statistics | Australia Risks

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 …

clinical-trials-medicinal-cannabis-studies

Clinical Trials: Setting up Your Cannabis Research Study

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 …

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 …