The standards will apply to both commercially produced and compounded MDMA and psilocybin, but not drugs used in clinical trials.
The TGA has released new quality standards for MDMA and psilocybin products supplied or manufactured in Australia, which will apply to both commercially manufactured and compounded medicines.
In July 2023, the TGA down-scheduled MDMA and psilocybin to Schedule 8 (controlled drugs), allowing them to be prescribed for PTSD and treatment-resistance depression respectively.
At the beginning of this year, the TGA closed a consultation into the proposed standards for the manufacture and supply of the two drugs.
The consultation received 25 submissions across the industry, with “broad in-principal support” for the standards, according to the TGA.
The new standards, which were released last week, incorporated recommendations from the consultation, including a transition period for manufacturers to comply with the new standards.
Manufacturers and suppliers have until 6 January 2025 to meet the new standards.
Respondents to the consultation strongly supported the requirement for compounding pharmacists to use active ingredients tested in Australian Good Manufacturing Practice (GMP)-licensed labs.
“Of the two respondents who did not agree, one required additional clarity regarding Australian licensing requirements,” said the TGA in the consultation outcomes paper.
“The second, a pharmacist, proposed that active primary ingredients manufactured overseas under GMP should be exempt from testing in an Australian GMP-licensed laboratory, as this poses additional restrictions for accessing MDMA for Australian patients, particularly those in clinical trials.”
The TGA said the requirement for Australian-based testing of the active ingredients would “ensure consistency of products supplied to Australian patients”.
“Consistent quality is essential to support the known safety and efficacy of any medicine,” it said.
“The therapeutic goods order will not apply to goods supplied and imported for use under the clinical trial notification and clinical trial approval schemes.”
Bioxyne-subsidiary Breathe Life Sciences is currently the only GMP-licensed manufacturer of psilocybin and MDMA in Australia, as far as it is aware, a spokesperson for the company told The Medical Republic.
They said the group reviewed the proposed standards during the consultation and welcomed the new quality standards.
Respondents also encouraged changes to the assay limits – the amount that the measured amount of drug can deviate from the labeled amount – and the impurity limits.
The standards were updated with “purity” requirements, rather than “stated content”, which are 98-102% for MDMA and 80-120% for psilocybin.
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The TGA told TMR amendments were made to the standards regarding tests.
Specifically, the removal of specific tests for acetic acid and impurities from the standard for MDMA as this was included in the test for residual solvents and the removal of a test for the concentration of psilocin in psilocybine isolate and synthetic psilocybine as this was covered by the specified tests for impurities.
Respondents also recommended using the United States Pharmacopeia or ICH guidelines, rather than the European Pharmacopoeia guidance.
The guidelines incorporated the ICH guidelines for heavy metal limits and said more direction would be included in the guidance material, which would be published in the future.
The TGA told TMR that the guidance documents had been finalised and were expected to be released within the month.
This article was updated at 5pm on 2 September with comments from the TGA and additional comments from BLS.
