1.

Notifying Member: AUSTRALIA

If applicable, name of local government involved (Article 3.2 and 7.2):

2.

Agency responsible:

Therapeutic Goods Administration, Department of Health and Aged Care

Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:

Australian WTO TBT Enquiry Point

Office of Global Trade Negotiations

Department of Foreign Affairs and Trade

Canberra ACT 0221 tbt.enquiry@dfat.gov.au

+61 2 6261 1111

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], other:

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Medicines

5.

Title, number of pages and language(s) of the notified document: Consultation paper – Proposed quality standards for MDMA and psilocybin; (36 page(s), in English)

6.

Description of content: 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 Psilocybin

The 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.

7.

Objective and rationale, including the nature of urgent problems where applicable: The proposed TGOs have been developed in consultation with manufacturers making MDMA and psilocybin for clinical trials and are based on the current methodologies and testing limits used by these manufacturers, for both the active pharmaceutical ingredient (API) and finished product.

The TGOs will provide medical practitioners and the Australian public confidence that these goods meet quality expectations for safety and efficacy.

The public consultation on the draft TGOs allows manufacturers, medical practitioners, patients and other interested stakeholders the opportunity to comment on the proposed quality requirements.

The TGA expect to finalise the TGOs in February 2024 and register them on the Federal Register of Legislation in March 2024. The TGA propose to implement the requirements from the date of commencement of the TGOs.; Protection of human health or safety

8.

Relevant documents:

The consultation paper is available at https://consultations.tga.gov.au/tga/proposed-quality-standards-for-mdma-and-psilocybin

9.

Proposed date of adoption: Aiming for February 2024, with consideration to be made based on the number of comments and submissions received.

Proposed date of entry into force: March 2024

10.

Final date for comments: 31 January 2024

11.

Texts available from: National enquiry point [ ] or address, telephone and fax numbers and email and website addresses, if available, of other body:

TGA website: https://www.tga.gov.au/resources/consultation/consultation-proposed-quality-standards-mdma-and-psilocybin

Consultation hub: https://consultations.tga.gov.au/tga/proposed-quality-standards-for-mdma-and-psilocybin