GMP Clearance: Temporary changes to target processing times

GMP Clearance assessment target timeframes are temporarily increasing by 30 TGA working days (6 calendar weeks) across all compliance verification application types. This increase will take effect immediately for all in-process applications.

These changes will be reviewed at the end of the financial year (June 2023).

If you suspect these increases will affect your regulatory functions, you can make a request for us to prioritise your application as per the GMP Clearance Guidance. Please note however that our current priorities remain COVID-19 vaccines and treatments and confirmed medicines shortages.

There is no change to the MRA pathway and the new CV target timeframes remain within the legislated timeframes for product registration submissions (where applicable).

Background information

Existing timeframes were introduced in collaboration with the TGA Industry Working Group on GMP (TIWGG) following the resolution of the GMP Clearance back-log in 2019. The selected values were based on a combination of:

• available resources
• assessment complexity 
• volume of applications received at that time.

Since these timeframes were introduced in 2018/2019 financial year, we have experienced a significant increase (~36%) in the volume of GMP clearance applications (6627 -> 9007).

Additionally, the complexity of assessments has increased due to the lack of primary evidence available during the COVID-19 pandemic. This has required us to perform a more in-depth assessment of additional manufacturer documentation.