We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Automatic extension of MRA and non-sterile API GMP clearances start today. We will advise in the coming weeks when this work is completed and next steps.
Please note that the GMP clearance questionnaire has been removed from the TGA website and is no longer available for use in applications submitted from today.
Webinar
We held a webinar on Thursday 19 June providing further information about the backlog reduction strategy. The presentation slides are available and a recording will be made available in due course.
For information on the GMP clearance backlog reduction strategy, please refer to our recent notice on the TGA website.