We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.

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.

Official version of legislation
The Federal Register of Legislation is the authorised Australian Government website for Commonwealth legislation. It contains the full text and details of the life cycle of individual laws.

Read the legislation

Guidance referring to this legislation

Preparing for Good Clinical Practice (GCP) inspections

4 November 2024

Guidance

Clinical trials of medicines and biologicals regulated under the CTN or CTA schemes are subject to the TGA's Good Clinical Practice (GCP) inspection program.

Topics