GMP Clearance: Extension processing times

We are currently experiencing extremely high volumes of GMP Clearance extension applications which is resulting in delays to processing timeframes. Sponsors may experience instances where an extension application is only processed after the expiry date of their existing GMP Clearance.

What sponsors need to do

• Continue to submit extensions to your GMP Clearance where you meet the criteria to do so.
• Submit extension applications at least 1 month prior to the expiry date of your GMP Clearance.
• Only contact the GMP Clearance team if your expired GMP Clearance is affecting a regulatory submission to list, register or vary a product on the ARTG.

Background

The number of GMP Clearance extension applications has significantly increased through-out the COVID-19 pandemic for several reasons including:

• Ongoing travel restrictions delaying the return of international GMP inspections to pre-pandemic levels
• Longer processing times for GMP Clearance assessments as a result of new processes introduced during the pandemic
• Delays to TGA inspections

Additionally, processing times have been affected by:

• Prioritisation of extensions linked to medicine shortage notification and COVID-19 vaccine and treatments
• Extension applications being submitted less than 1 month prior to expiry
• Increases to the number of “re-instatement” requests due to Sponsors allowing their GMP Clearances to expire for more than 30 days. These take considerably longer to process.