Therapeutic Goods (Clinical Trial Inspections) Specification (No. 2) 2020

This Specification facilitates the release of specified therapeutic goods information relating to clinical trials to specified persons or bodies.

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Guidance referring to this legislation

Preparing for Good Clinical Practice (GCP) inspections

27 March 2025

Guidance

Guidance on GCP inspections for clinical trial sites of investigational biologicals, medicines and medical devices regulated under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) schemes.

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