Purpose
This guidance is to assist manufacturers and sponsors to understand the requirements for compliance with the new quality standards for MDMA and psilocybine active pharmaceutical ingredient (API) and finished product.
Legislation
New quality requirements for MDMA and psilocybine have been registered as Therapeutic Goods Orders (TGO), established under Section 10 of the Therapeutic Goods Act 1989 (the Act) as of 21 August 2024:
- Therapeutic Goods (Standard for MDMA) (TGO 112) Order 2024
- Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024
The TGOs commence on 6 January 2025. This delay in implementation allows manufacturers and testing laboratories time to develop and validate methods for testing the active pharmaceutical ingredients (API) and finished product. All MDMA and psilocybine products manufactured or supplied in Australia must comply with the relevant TGO, unless they are exempt.
Penalties
There are offence provisions in the Therapeutic Goods Act 1989 (the Act) for the import, export and supply of medicines that do not comply with a relevant standard. These provisions apply to everyone in the supply chain, not just the sponsor.
For more information on how we approach and manage compliance with therapeutic goods, visit our compliance management website.
If your MDMA or psilocybine product is found to be unsafe, we can take regulatory action, regardless of the commencement date of a standard.
What the standards apply to
The quality requirements in Therapeutic Goods (Standard for MDMA) (TGO 112) Order 2024 apply to:
- MDMA hydrochloride API
- MDMA hydrochloride finished product
imported into, supplied in or exported from Australia.
The quality requirements in TGO 113 (Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024) apply to:
- psilocybine plant-derived API
- psilocybine plant-derived finished products
- psilocybine synthetic API
- psilocybine synthetic product
imported into, supplied in or exported from Australia.
The quality requirements in TGO 112 and TGO 113 do not apply to products:
- supplied and imported for use under the clinical trial notification (CTN) and clinical trial approval (CTA) schemes.
- imported by certain groups of people subject to conditions. The groups of people include those:
- mentioned in item 1 of Schedule 5 to the Therapeutic Goods Regulations 1990 (the Regulations) or
- mentioned in items 4, 8, 10, 11 or 12 of Schedule 5A to the Regulations, subject to compliance with the conditions specified in those items.
Restrictions for MDMA and psilocybine
You can only manufacture and supply certain types of MDMA and psilocybine products in Australia.
The medicines are restricted in the following ways:
- MDMA must be MDMA hydrochloride.
- Plant-derived psilocybine is restricted to a single mushroom species, Psilocybe cubensis.
- The dosage form for both medicines is restricted to capsules.
Supply of any product that does not meet these restrictions is unlawful.
Tests
Your API and finished products must meet the requirements set out in the schedules to the TGOs.
The test methods included in the schedules are considered the most relevant and up to date testing methodologies to achieve a consistent API and finished product. You do not have to use these methods, you could use alternatives such as:
- equivalent methods in established pharmacopoeia, including the United States Pharmacopoeia-National Formulary, or
- suitably validated in-house tests.
However, in the event of a disputed result, the test methods specified in the TGOs are the official methods for testing of the respective therapeutic good and must be used.
Additional tests
The TGOs are ‘minimum quality standards’ and do not limit you from including additional tests in your own testing program. Additional tests could include:
- Loss on ignition.
- Description and appearance.
- Dissolution.
- Nitrosamines.
Alternative synthesis pathways
Whatever process you use to manufacture a synthetic substance, you need to consider what impurities will be present based on that manufacturing pathway. This could mean you need to perform other tests, in addition to those in the relevant TGO, to ensure appropriate quality and safety.
Nitrosamines
We have published acceptable intake (AI) information for nitrosamine impurities in medicines consistent with recent European Medicines Agency updated information.
Sponsors and manufacturers are expected to be familiar with the current acceptable intakes (AI) for nitrosamine impurities in medicines that we consider acceptable. This is detailed on our website.
Nominated tryptamines
If your product is plant-derived psilocybine and its therapeutic claims rely on the presence of tryptamines in addition to psilocybine and psilocin, you must nominate them and test the product to ensure consistent quality. The test and the quality requirements are set out in the schedule to TGO 113.
Tryptamines present in psilocybine products are defined as ‘the group of monoamine alkaloids, excluding psilocybine and psilocin, derived from the amino acid tryptophan’.
Compounding MDMA and psilocybine capsules
If you are compounding and are exempt from the requirement to hold a manufacturing licence from the TGA, there are specific testing requirements that apply to these products. The API used to compound an MDMA or psilocybine finished product must be:
- tested against, and show compliance with, the requirements of the TGO and
- the testing must be conducted at a site that holds a manufacturing licence from the TGA.
Labelling
You may need to consider other labelling requirements for your MDMA or psilocybine product, such as those in the Poisons Standard.
Other relevant standards
MDMA and psilocybine products may have to comply with other quality standards under the Act. It is the responsibility of the sponsor to ensure the API or finished product complies with all relevant legislative requirements.
For example: