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 the world. A market of particular interest is Germany, in which 60,000 patients registered for medicinal cannabis products in 2019, which…
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 regulated under the existing medical device framework, however a reform is required to keep up with the latest technological advances….
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 the globe? And how many fake medicines are entering Australia’s pharmaceutical supply chains? Once primarily seen in low-income regions, the phenomenon…
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 medications? In this blog, we’ll provide a basic overview of setting up a clinical research trial for medicinal cannabis. Reading time:…
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 required for the manufacture of medicinal cannabis active pharmaceutical ingredients (API), for example, if: Depending on the dosage form…
On October 31, the ODC released an online smart form and “flat” paper forms to apply for a cultivation, production or research medicinal cannabis licence. This online form can also be used if you seek a manufacturing licence but ONLY if you are also applying for a cultivation and/or production licence or a research licence….
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 2016 this is is the fifth update of the Australian Complementary Medicine Guidelines since 2013. This is This short blog is to draw your attention to…
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 evolving legislative changes around both cultivation and patient access to medicinal cannabis, have many Australian cultivator and manufacturing innovators on high…
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