PV Bulletin

Checklist for Prescribing Psychiatrists of MDMA and Psilocybine

TGA released a new checklist for prescribing psychiatrists to ensure compliance with clinical and safety monitoring requirements for MDMA and psilocybine.

Primary source: https://www.tga.gov.au/resources/resource/checklist-prescribing-psychiatrists-mdma-and-psilocybine

PV Impact Brief

MonitoringConfidence: high

What changed

TGA published a new checklist requiring prescribing psychiatrists to document adherence to clinical protocols and safety monitoring, including adverse event reporting for these unapproved substances.

Why it matters

This checklist formalizes safety reporting expectations for MDMA and psilocybine prescriptions, ensuring consistent monitoring and ICSR submission to the TGA.

Action needed

Review and implement the TGA checklist for all psychiatrist prescribers of MDMA/psilocybine; update ICSR workflows to capture adverse events as per checklist requirements.

Relevant for
Regulatory Intelligence LeadQPPV
Processes impacted
Country ComplianceICSR
Owner

Regulatory Intelligence Lead

Review cadence

monthly

Policy change details

Document type
Checklist / Form
Policy status
effective
Publication date
2026-06-11
Policy change
A new checklist released to support psychiatrists who are authorized prescribers of MDMA and psilocybine, ensuring compliance with clinical and safety monitoring requirements.

Key changes

New compliance checklist for psychiatrists covering clinical protocol adherence and safety monitoring for MDMA and psilocybine.

Affected workflows

Country ComplianceICSR

Responsible groups

Clinical OperationsMedical AffairsPharmacovigilance

PV impact

Prescribing psychiatrists must use this checklist to ensure all safety monitoring and reporting obligations for these unapproved substances are met, including adverse event reporting to the TGA.

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 11, 2026

Full briefing

Practical implication

Review and implement the TGA checklist for all psychiatrist prescribers of MDMA/psilocybine; update ICSR workflows to capture adverse events as per checklist requirements.

The TGA issued a compliance checklist for psychiatrists authorized to prescribe MDMA and psilocybine, outlining safety monitoring and adverse event reporting obligations.

What changed: TGA published a new checklist requiring prescribing psychiatrists to document adherence to clinical protocols and safety monitoring, including adverse event reporting for these unapproved substances.

Why it matters: This checklist formalizes safety reporting expectations for MDMA and psilocybine prescriptions, ensuring consistent monitoring and ICSR submission to the TGA.

Practical implication: Review and implement the TGA checklist for all psychiatrist prescribers of MDMA/psilocybine; update ICSR workflows to capture adverse events as per checklist requirements.

View original source

Published from the Firecrawl policy change extraction pipeline.

#MDMA#Psilocybine#Compliance Checklist#Safety Monitoring#Checklist / Form#effective#Therapeutic Goods Administration (TGA)#reporting_requirement

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