The manufacture of medicines for initial experimental studies in human volunteers (which generally means first-in-human trials, which are generally, but not always, Phase 0 and Phase I trials) is not subject to inspection and licensing by the TGA (specified in item 1, Schedule 7, Therapeutic Goods Regulations 1990). However, the Australian manufacture of all other clinical trial medicines is subject to inspection (including Annex 13) and licensing by the TGA.
Manufacturers in Australia of investigational medicinal products for clinical trials in phase 3 and phase 2 that are not initial experimental studies in human volunteers must hold a valid TGA licence that specifically authorises that site for the manufacture of clinical trial products.
Even if a pilot facility is dedicated for the development of dosage forms and new products, and is not used for the manufacture of saleable product, it is still subject to TGA inspecting and licencing if it is used to manufacture investigational medicinal products for clinical trials that are not initial experimental studies in human volunteers.
Labelling investigational medicines
'Certain characteristics' in clause 32 of Annex 13
The 'certain characteristics' in clause 32 of Annex 13 of the PIC/S Guide to GMP for medicinal products refers to non-commercial clinical trials performed by researchers without the participation of the pharmaceutical industry. The requirements in this clause relate to the way these products are to be labelled.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.