C4C: MDMA and Psilocybine
Tracks
Courtyard Room Seminar
| Tuesday, November 19, 2024 |
| 3:30 PM - 4:00 PM |
Details
On 1 July 2023 we created entries for MDMA and psilocybine under Schedule 8 of the Poisons Standard. This allowed the prescribing of these medicines by specialist psychiatrists who are authorised under the authorised prescriber scheme, in addition to continued patient access through clinical trials.
Australia is one of the first jurisdictions to allow access to these medicines, as such there are currently no international quality standards, such as pharmacopoeial monographs, for these medicines. We have created two new therapeutic goods orders (TGOs) for these substances that set out the requirements that must be met to ensure medicines are of appropriate quality.
This session will provide an overview of the new TGOs to help manufacturers and sponsors understand the minimum quality requirements that must be met for both the active pharmaceutical ingredients (API) and finished products. This session will also outline the specific licence authorisations and conditions to manufacture these substances.
Speaker: Nicole Bottle, Assistant Director, GMP operations and Strategy Section
Speaker: Nicole is an Assistant Director in the GMP Operations and Strategy Section of Manufacturing Quality Branch. Nicole joined the TGA in October 2023 to manage regulatory reform work within the branch, and has focused on reforms to the regulation of medicinal cannabis, MDMA and psilocybine. Prior to joining the TGA, Nicole was at the Department of Agriculture, Fisheries and Forestry working on a range of projects to implement regulatory controls to manage biosecurity risks.
Australia is one of the first jurisdictions to allow access to these medicines, as such there are currently no international quality standards, such as pharmacopoeial monographs, for these medicines. We have created two new therapeutic goods orders (TGOs) for these substances that set out the requirements that must be met to ensure medicines are of appropriate quality.
This session will provide an overview of the new TGOs to help manufacturers and sponsors understand the minimum quality requirements that must be met for both the active pharmaceutical ingredients (API) and finished products. This session will also outline the specific licence authorisations and conditions to manufacture these substances.
Speaker: Nicole Bottle, Assistant Director, GMP operations and Strategy Section
Speaker: Nicole is an Assistant Director in the GMP Operations and Strategy Section of Manufacturing Quality Branch. Nicole joined the TGA in October 2023 to manage regulatory reform work within the branch, and has focused on reforms to the regulation of medicinal cannabis, MDMA and psilocybine. Prior to joining the TGA, Nicole was at the Department of Agriculture, Fisheries and Forestry working on a range of projects to implement regulatory controls to manage biosecurity risks.
