Sub menu

 
 

New quality standards for MDMA and psilocybine

Published

Two new quality standards, one for MDMA and another for psilocybine, have been published. These standards each specify the minimum quality requirements for both the active pharmaceutical ingredient (API) and finished product.

Commencement 

The quality standards have been registered as Therapeutic Goods Orders (TGOs) on the Federal Register of Legislation:

From 6 January 2025, all MDMA and psilocybine API and finished products supplied or manufactured in Australia must comply with the relevant TGO. 

Guidance material 

We will publish guidance material to help manufacturers and sponsors understand how these TGOs set the minimum quality requirements that must be met for these medicines.

Topics

Related content

This webpage on the TGA website was printed on 12 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/news/news/new-quality-standards-mdma-and-psilocybine

Help us improve the Therapeutic Goods Administration site