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Research, Drug Development & Manufacturing

TGA DAEN

Also known as: Therapeutic Goods Administration Database of Adverse Event Notifications

Australian adverse-event notification database and safety-monitoring framework. Psychedelic relevance: TGA publishes dedicated policy and access guidance for MDMA and psilocybin use.

Real-World Data Snapshot

Verified

Verification

Verified

Coverage

1 country

Access Model

Open access

Last Verified

Apr 7, 2026

Methodology

DAEN publishes adverse-event notifications reported to Australian pharmacovigilance channels. As with spontaneous reporting systems, data is best used for signal detection and review.

Safety monitoring registriesWeeklySafety surveillance data

Primary Dataset

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Source Evidence

2 sources

TGA DAEN

https://www.tga.gov.au/safety/safety/safety-monitoring-daen-database-adverse-event-notifications/database-adverse-event-notifications-daen

TGA MDMA and Psilocybine Guidance

https://www.tga.gov.au/products/unapproved-therapeutic-goods/mdma-and-psilocybine

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