TGA Publishes Specification on Release of Information on Clinical Trials of Therapeutic Goods

On June 2020, The Therapeutic Good Administration (TGA ) of Australia has released The Therapeutic Goods (Clinical Trial Inspections) Specification stipulated under subsection 61(5AB.

Pursuant to  Subsection 61(5AA), the legislation permit the Secretary to release specific details on therapeutic goods on clinical trials involving therapeutic goods(other than medical devices ) to the approving authority and ethics committee.

The authority in the legislation refers to the person or body at whose site where a clinical trial is carried out (or conducted in part, for a clinical trial conducted at more than one site) and governs the trial.

This provision will ensure the safe and lawful conduct of the trial in compliance with good and ethical clinical practice.

Among the details comprised in the specification includes the authority responsible for the documenting the specification, the commencement date, the definition of terms used in the specification and the type of information that is permitted to be released to the category of authorities.

The vital information that may be released is listed in Schedule 1 of the Specification which includes compliance of the trial with the National Statement on Ethical Conduct in Human Research, the Guideline for Good Clinical Practice, and the procedural protocol approved for the trial by the ethics committee.

Further information can be obtained from https://www.tga.gov.au/specifications