GMP Clearance: Additional countries added to MRA pathway

Published

20 March 2023

More applications for Good Manufacturing Practice (GMP) clearances can now be assessed under the TGA’s MRA pathway, reducing the supporting evidence Australian sponsors need to submit to the TGA.

GMP Clearance applications are assessed via two pathways. These are the:

Mutual Recognition Agreement (MRA) pathway
Compliance Verification (CV) pathway.

Applications eligible for the MRA pathway require less supporting information, take less TGA assessment time and cost less. It can be used when the overseas manufacturing site has been approved by a regulatory authority with whom the TGA has an appropriate agreement or arrangement.

We have assessed the regulatory authorities in the following European countries:

Croatia
Estonia
Romania
Slovenia
Lithuania.

As members of the European Union (EU), these countries have been added to the list of those operationalised under the Australia-EU MRA for GMP Clearance.

This means that Australian sponsors can now submit GMP clearance applications relying on the evidence produced by these countries’ regulatory authorities. These options were previously not available.

If the inspection was performed within the borders of the country the MRA pathway can be used.

If the inspection was performed outside the borders of the country the CV pathway can be used.

The TGA eBusiness Portal will be updated on 20 March 2023 to reflect these changes. Existing applications will be processed as outlined below.

Submitted GMP Clearance applications

For any applications utilising evidence from these countries that were submitted but are not assessed prior to 20 March, we will:

process them as a ‘MRA’ application type
contact you regarding any fees paid and if the required evidence for the MRA pathway has not been provided.

Draft GMP Clearance applications

For draft applications not yet submitted to the TGA for assessment, please review and update the ‘Application Type’ and re-select the manufacturer details before submitting:

Go to TGA Business Services
On the left-hand menu, choose ‘Login to Business Services
On your homepage, click on ‘Work on drafts
Search for the relevant clearance application and edit your draft
Under ‘Application Details’ section, choose the appropriate ‘Application Type’.
On the ‘Client Details’ tab, under ‘Existing Manufacturer’ section, re-select you manufacturer details
Once you have updated the ‘Application Type’ and manufacturer details, click ‘Validate’ and ‘Save.