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Compounding Medicinal Cannabis vs GMP Manufacture

The TGA recently held a webinar to discuss the recent reforms to medicinal cannabis legislation and it included:

GMP requirements for imported products to level the playing field for local manufacturers
Updated labelling and packaging details in TGO 93.

FDA light touch on medical devices for patient self monitoring

PIC/S PE 009-16 update, Part 1 – changes to Annex 13

Historically, the PIC/S GMP Guide has chapters and annexes revised, aligned and corrected to close the gap between the international GMP guidelines and to further develop and harmonise GMP standards. PIC/S PE 009-16 (or version 16) of the Guide, …


The future of precision fermentation in our food

Advances in technology for food production, and precision fermentation itself was unexpectedly predicted by Winston Churchill in 1932:
“We shall escape the absurdity of growing a whole chicken in order to eat the breast or wing, by growing these parts …

medicinal cannabis

An ode to the ODC single licence and permit reforms

After a long wait, during what felt like an even longer year, the ODC has finally dropped a hot new legislative update (and just before we entered 2022 too). The title of this update? “Single licence and permit reforms”. …

PharmOut Innovation Dinner

Psychedelic Therapies in Australia – the next steps forward

After Mind Medicine’s very successful International Summit on Psychedelic Therapies for Mental Illness, I’m sure the nascent industry is ablaze with ideas and inspiration.

The down-scheduling decision on MDMA and psilocybin is due to be released in Dec 2021, and …

TGA Updates for Medicinal Cannabis

The TGA recently held webinars about reforms that impact the medicinal cannabis industry, including:

Changes to prescribing medicinal cannabis through the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathways
The removal of TGO 93 Standard for Medicinal Cannabis …

GMP Vendor Management Audit Program

Supplying Medicinal Cannabis in Australia

The TGA recently held a webinar called ‘Meeting Your Obligations – Supplying medicinal cannabis in Australia,’ and while it was useful as an overview of the therapeutic good development lifecycle, it did not delve too much into the main …