TBT BSN | Notification

Notification Detail :: G/TBT/N/AUS/165

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Consultation paper – Proposed quality standards for MDMA and psilocybin

Objective

Protection of human health or safety (TBT)

Product Covered

Medicines

Document Notification

Link to ePing

HSCODE

30 - PHARMACEUTICAL PRODUCTS

ICSCODE

11.120 - Pharmaceutics

Keywords

Specific Regions

Description

The Therapeutic Goods Administration (TGA) administers Australia’s national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods in Australia. There are provisions under the Therapeutic Goods Act 1989 to establish quality standards for therapeutic goods. These standards, known as TGOs, can specify things such as procedures to be carried out in the manufacture of the goods, labelling, or other requirements. Once approved, TGOs are registered as legislative instruments on the Federal Register of Legislation in Australia.The TGA has developed two new quality standards that will be registered as legislative instruments on the Federal Register of Legislation in Australia as Therapeutic Goods Orders (TGOs):Standard for MDMA hydrochloride, and Standard for PsilocybinThe TGA is undertaking a public consultation between Friday 8 December 2023 to Wednesday 31 January 2024 to seek feedback on the appropriateness of the requirements in the TGOs.Until 1 July 2023 Australian patients only had access to therapy with ,4‑methylenedioxy‑N-methylamphetamine hydrochloride (MDMA) and psilocybin as part of clinical trials. Effective from 1 July 2023, the TGA amended the Poisons Standard to add MDMA and psilocybin to Schedule 8 (S8), permitting their use as Controlled Drugs only for the treatment of post-traumatic stress disorder (PTSD) and treatment resistant depression (TRD), respectively. Only authorised medical practitioners are permitted to prescribe S8 MDMA and psilocybin.There are no quality standards such as pharmacopoeial monographs or TGOs for MDMA or psilocybin. The TGA has developed manufacturing and testing requirements that will form the basis of proposed new TGOs for each of these medicines.

Notified Document

1:File here

Link to Notification

EN:File here

ES:File here

Status Active

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Notification Detail :: G/TBT/N/AUS/165

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