Australia Profile Updated in ClinRegs
October 15, 2020
The Australia profile in ClinRegs has been reviewed and updated to reflect current requirements, including:
- New contact details for the Therapeutic Goods Administration (TGA) (See Regulatory Authority)
- The updated Clinical Trial Notification (CTN) form user guide, which describes minor changes to the online CTN form, such as auto-population of contact details and updated submission processes (See Submission Content and Trial Authorization)
- The TGA’s Interpretation and Expectations for Demonstrating Compliance with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE009-14 (See Labeling & Packaging)