TGA updates on GMP clearance for an overseas manufacturing site

This post the following TGA updates on GMP clearance for an overseas manufacturing site:

GMP clearance sponsor information dashboard and guidance updates
GMP clearance: Mutual Recognition Agreement (MRA) and Compliance Verification (CV) pathway updates

1. GMP clearance sponsor information dashboard and guidance updates

This update concerns sponsors seeking to obtain Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site used in the manufacture of a medicine, or an Active Pharmaceutical Ingredient (API) used in a medicine, intended for supply in Australia.

Sponsor Information Dashboard

TGA has created a new GMP clearance Sponsor Information Dashboard (SID) to provide industry with current information relating to GMP clearance. The new page will be updated monthly and provide information on:

processing timeframes for each application stream
current work on hand in the GMP clearance section
current priorities
key messages and updates.

You can view the dashboard here.

GMP clearance application and submission user guide

In consultation with the TGA-Industry Working Group on GMP (TIWGG), the TGA has also updated the GMP clearance guidance document.

Whilst this update contains minor amendments to content, the guidance has been in two, thereby separating the tBS portal submission steps into a standalone document.

As such the GMP clearance guidance documents now consist of the follwoing two guidance documents.

GMP clearance guidance ( version 18.4 November 2023)
GMP clearance application and submission user guide v1.0 (November 2023)

This guidance is not intended for sponsors of:

biologicals, human blood and blood components and Haematopoietic Progenitor Cells (HPCs), because Australia has its own manufacturing standard for these product types; however, where the manufacturing site performs only sterilisation of these product types, this guidance may be used
some complementary and listed medicines, including sunscreens, because these may not be regulated as medicines in other countries.

Further information is available in the Australian manufacturing licences and overseas GMP certification guidance here.

2. GMP clearance: Mutual Recognition Agreement (MRA) and Compliance Verification (CV) pathway updates

TGA has reviewed and updated its temporary measures for processing GMP clearances via the Mutual Recognition Agreement (MRA) and Compliance Verification (CV) pathways. This ensures Australian sponsors can maintain the validity of their GMP clearances and supply of goods to Australia.

MRA GMP clearances expiring between 31 December 2023 and 31 December 2024

Current GMP clearance expiry date	Action
31 December 2023	An extension application is not needed as the TGA will automatically extend your GMP clearance until 31 December 2024 and existing extension applications will be removed from the TGA Business Services portal.
After 31 December 2023	Please submit an extension application as per the GMP clearance guidance.

State of current GMP evidence	Action
More than 3 years old and you have not submitted a renewal application that has been assessed using our risk-based approach	Please submit a renewal application as per the GMP clearance guidance. The application will be assessed using an updated risk-based approach.
Less than 3 years old	Please submit a renewal application as per the GMP clearance guidance. The application will be assessed using the existing routine processes.

Source: TGA (sponsor information dashboard and guidance); TGA (MRA and CV pathway)