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Class 4 biologicals
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The trial sponsor must identify the type(s) of therapeutic good(s) used in the trial in a CTN or CTA submission.
The 'Determine the type of therapeutic good' webpage provides guidance on the different types of therapeutic goods.
Class 4 biologicals
Biologicals are grouped into four classes. The CTA scheme is mandatory for clinical trials involving certain Class 4 biologicals. The Therapeutic Goods Regulations 1990 and the Australian regulatory guidelines for biologicals (ARGB) specify what a Class 4 biological is.
Question
Are any of the 'unapproved' therapeutic goods considered to be Class 4 biological(s)?