GMP Clearance: Backlog Reduction Strategy Update
22 Sep 2025
The strategy included three main measures:
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Automatic extension of existing Mutual Recognition Agreement (MRA) and non-sterile Active Pharmaceutical Ingredient (API) GMP clearances set to expire between 1 July 2025 and 30 June 2027.
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Abbreviated evaluation of manufacturing sites performing certain lower-risk activities.
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Ending COVID-19 regulatory flexibilities, including the GMP Clearance Questionnaire.
All strategies have now been put into place, and the backlog is reducing as expected. The GMP Clearance Sponsor Information Dashboard (SID) has also been updated with more data and insights.
Automatic extensions
Between 1–10 July, over 6,200 GMP Clearances were automatically extended. Of 887 related applications in the lodgement system, 430 were closed as no longer required. The remaining applications, either with newer evidence or seeking increased scope, will be processed over the coming months.
Abbreviated evaluations
Evaluations for certain lower-risk manufacturing sites have begun and will continue as the backlog is cleared. Evidence requirements for GMP Clearance applications remain unchanged.
Ending COVID-19 flexibilities
From 1 July, the GMP Clearance Questionnaire is no longer accepted. Evidence availability has not caused major issues as global GMP inspections return to normal. Sponsors are encouraged to work with manufacturers to ensure evidence meets TGA requirements, or submit a Certification application if it does not.
Progress reporting
The TGA will continue to monitor the effectiveness of these strategies. Updates will be shared via the GMP Clearance SID and with industry through the TGA-Industry Working Group on GMP (TIWGG).
Source: Therapeutic Goods Administration (TGA)
