New quality standards for MDMA and psilocybine

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:

• Therapeutic Goods (Standard for MDMA) Order 2024 (TGO 112)
• Therapeutic Goods (Standard for psilocybine) Order 2024 (TGO 113).

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.