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TGA suspends overseas GMP inspections and QMS audits until further notice
3 July 2020
We have introduced several new processes for the ongoing regulation of domestic and overseas manufacturers during the COVID-19 pandemic.
Consistent with the Australian Government's latest travel restrictions, the Therapeutic Goods Administration (TGA) has suspended all overseas GMP (Good Manufacturing Practice) on-site inspections and QMS (Quality Management System) audits until further notice.
In addition to our commitment to ensuring that overseas manufacturers meet GMP and QMS requirements, we are also mindful of the need to provide transparent information to sponsors affected by these delays. Sponsors immediately affected by the suspension to GMP inspections have been contacted and, where applicable, advised about maintaining the validity of their existing GMP clearances.
The TGA is committed to working with Australian sponsors and manufacturers during this time. Our staff are available to assist via the contact information below:
- For domestic and overseas inspections and general GMP enquiries, contact the Licensing and Certification Section: GMP@health.gov.au
- For overseas GMP Clearance desk-top assessments and extensions to GMP Clearances, contact the GMP Clearance section: GMPClearance@health.gov.au
- For domestic and overseas inspections and general medical device QMS enquiries, contact the Device Quality Audits and Assessment Section: QMS.Certificates@health.gov.au
For phone enquiries, please use the general TGA information line and ask to speak to the relevant team outlined above:
- 1800 020 653 (free call within Australia)
- +61 2 6232 8644 (overseas call)
- 02 6232 8644 (for mobiles that do not allow 1800 calls)
Additional information about the TGA's response to coronavirus (COVID-19) is available on our website.