Every year, the Therapeutic Goods Administration (TGA) undertakes a comprehensive targeted consultation by engaging with peak therapeutic industry bodies in regard to the TGA fees and charges being proposed for the upcoming financial year, including TGA application fees for pharmaceutical products/biologicals, chemicals, and medical devices. The TGA is required to recover its costs for all…
During a webinar last year, the TGA announced they were intending to introduce changes to the medicinal cannabis regulations (including supplier assurance requirements for imported medicinal cannabis products). In light of that, a TGA consultation on potential reforms to medicinal cannabis manufacturing, labelling and packaging has just closed. As a result, there are three key…
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 one of the last things we were asked to do as participants of the summit…
Glancing at headlines these days there appears to be a consistent stream of positive news breaking out all over the world about the potential therapeutic benefits of psychedelics, including a declaration from the FDA that psilocybin is a “breakthrough therapy.” Australia has also been involved in conducting some of the research and there are ongoing…
What is a Unique Device Identifier (UDI)? Unique Device Identifier (UDI) is a globally unique series of characters for each medical device on the market to: The Unique Device Identifier of a medical device typically includes two parts: History of UDI The first concept of UDI was signed into US law and added as part…
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