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

5 June 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.

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