Australia’s TGA Unveils Handbook of Guidance on Clinical Trials

Regulatory NewsRegulatory News | 16 March 2018 |  By 

Austalia’s Therapeutic Goods Administration (TGA) on Thursday released a new clinical trial handbook, offering guidance on the legislative, regulatory and good clinical practice (GCP) requirements for conducting clinical trials in Australia.

The 55-page handbook guides trial sponsors and principal investigators, Human Research Ethics Committees (HRECs), and approving authorities (institutions in which the trial is being conducted) on unapproved therapeutic goods, which covers medicines, medical devices and in vitro diagnostics, biologics and three other types of products.

There are two schemes in Australia under which clinical trials involving unapproved therapeutic goods may be conducted: The Clinical Trial Notification (CTN) scheme and the Clinical Trial Exemption scheme.

“Under the CTN scheme, if we direct the trial not be conducted or become aware that to conduct or continue the trial would be contrary to the public interest then the goods used in the trial would no longer be exempt from inclusion in the ARTG [Australian Register of Therapeutic Goods],” the handbook says. “For example, this may be where it comes to our notice that allowing the trial to proceed or continue carries an unacceptable risk of death, serious illness or serious injury.”

And under both schemes, the use of therapeutic goods in a trial must be in accordance with Australia's "Guideline for Good Clinical Practice," the "National Statement" and the protocol approved by the HREC responsible for monitoring the trial.

The handbook also discusses the various roles and responsibilities under Australia’s therapeutic goods legislation. Throughout the handbook, references are made to other relevant publications and guidance to be consulted, including those from TGA, ICH, ISO and PIC/S.

Australian Clinical Trial Handbook

Australian Clinical Trials website


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