The TGA are proposing two minor amendments to the Therapeutic Goods Regulations 1990 and Therapeutic Goods (Medical Devices) Regulations 2002 to clarify the legislation and ensure it remains fit for purpose.

• The first minor amendment is to include wording to allow remote or hybrid GCP inspections of a clinical trial site under regulation 12AC and 7.4 of the regulations respectively. From time to time there may be benefits in the TGA undertaking such inspections remotely, including avoiding delays associated with attending on-site, and minimising the potential impacts of an on-site inspection on trial sponsors and participants, and TGA personnel. These include minimising disruption to the trial and avoiding unnecessary travel for authorised officers. Remote inspections have been used in other contexts, in particular of manufacturing premises, and are considered robust and effective in terms of being able to verify and ensure the safety of inspected sites. This will align with the intention of the GCP Inspection Program, which is to include a combination of on-site, remote and hybrid inspections.

• The second is a minor amendment to both sets of regulations which currently refers to therapeutic goods/medical devices ‘to be used’ in a clinical trial. Amendments are therefore proposed to ensure the clinical trial exemptions cover when products are also actually used in a clinical trial. 

Please email any comments or queries directly to Tessa Sherry via ClinicalTrials@health.gov.au or 02 5132 3523

Review time deadlines are very tight. Please contact Tessa by Friday 12 September if there are any concerns or if you require any additional time to review this proposal.