Proposed quality standards for MDMA and psilocybin

Closed 31 Jan 2024

Opened 8 Dec 2023

Contact

1800 020 653

GMP@health.gov.au

Feedback updated 16 Jul 2024

We asked

Between 8 December 2023 and 31 January 2024, we undertook a public consultation to seek feedback on the appropriateness of the proposed requirements in the draft quality standards for MDMA and psilocybin.

You said

We received 25 submissions from sponsors, manufacturers, pharmacists, health-care practitioners, industry associations, patients and members of the public.

There was broad in-principle support for the proposed quality standards for MDMA and psilocybin, however a number of suggestions for minor technical changes were recommended:

  • Changes to the assay limits for active pharmaceutical ingredients (API) and finish product for both MDMA and psilocybin.
  • Changes to the testing limits for impurities, heavy metals, and residual solvents.
  • Employing United States Pharmacopeia (USP) or International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines as an alternative to European Pharmacopoeia methods and limits.
  • Including additional testing, such as loss on ignition, appearance and content uniformity.
  • Including a transition period to allow sufficient time to develop and validate methods for testing the APIs and finished products.

All submissions that gave permission to be published on our website are available through the ‘View submitted responses’ link below.

We appreciate all the feedback and thank all respondents for their submissions.

We did

We have considered all of the submissions, and in response, some minor amendments will be made to the draft standards for MDMA and psilocybin.

A summary of the responses, the rationale for our decisions and the proposed changes are outlined in the Proposed quality standards for MDMA and Psilocybin – Consultation outcomes paper.

The quality standards will be registered as Therapeutic Goods Orders (TGO) on the Federal Register of Legislation in mid-2024 and will have a commencement date of 6 January 2025 to allow industry time to develop and validate test methods.  

Published responses

View submitted responses where consent has been given to publish the response.

Overview

The Therapeutic Goods Administration (TGA) is consulting on two proposed new quality standards for:

  • 3,4‑methylenedioxy‑N-methylamphetamine hydrochloride (MDMA), and
  • psilocybin.

The proposed standards include limits on contaminants and synthetic impurities, and accuracy in statement of active ingredients for MDMA and psilocybin. The standards would apply to both compounded and commercially manufactured medicines.

Quality standards provide medical practitioners and the Australian public confidence that these goods meet quality expectations to support their safe use and effectiveness.

Why your views matter

We are seeking comment to confirm the technical requirements outlined in the proposed quality standards for MDMA and psilocybin, specifically:

  • Assay limits and specified tests for MDMA and psilocybin.
  • Limits for impurities, residual solvents and heavy metals.
  • A specific requirement for compounders to use an active pharmaceutical ingredient (API) tested in an Australian Good Manufacturing Practice (GMP)-licensed laboratory.

We are not seeking comment on the decision to publish new quality standards for MDMA and psilocybin.

What happens next

Submissions will be reviewed by the TGA. A summary of responses will be published and all submissions will be placed on this website (unless marked confidential or indicated otherwise in submission form).

Outcomes from the consultation will be provided to the Government for consideration.

Audiences

  • Health professionals
  • General public
  • Industry
  • Sponsors
  • Manufacturers
  • Prescription medicines

Interests

  • Regulatory policy
  • Mental health