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PE009-13, the PIC/S guide to GMP for medicinal products

TGA interpretation and expectations for demonstrating compliance

2 January 2018

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Investigational medicinal products (Annex 13)

The Australian clinical trials handbook version 2.0 (to be published early 2018) contains guidance on manufacturing products for clinical trials.

Manufacture in Australia

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 I trials) is not subject to inspection and licensing by the TGA (specified in item 1, Schedule 7, Therapeutic Goods Regulations 1990). However, the domestic 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 (IMPs) 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 Good Manufacturing Practice for medicinal products refers to non-commercial clinical trials performed by researchers without the participation of the pharmaceutical industry. These trials are usually performed with registered (or listed) products that are obtained from the market for use in a clinical trial. The requirements in this clause relate to the way these products are to be labelled.

Book pagination