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GMP clearance guidance

Version 18.1, January 2019

4 January 2019

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Step 2 - Identifying the appropriate GMP clearance pathway

What country your manufacturer is located in and which regulatory authority inspected the site will determine which pathway is appropriate for obtaining your GMP clearance.

We have entered into various international agreements and arrangements, some of which allow us to use the evidence from inspections conducted by overseas regulatory authorities as part of the GMP clearance process.

Mutual Recognition Agreements (MRA)

Use the MRA pathway if the manufacturer you are seeking GMP clearance for is located within the borders of a MRA country, and has been inspected by that country's regulatory authority.

Compliance Verification (CV)

Use the CV pathway if the manufacturer you are seeking GMP clearance for does not meet the criteria for the MRA pathway and has been inspected by a regulatory authority that has an agreement or arrangement with the TGA.

You can only use the MRA and CV pathways if the regulatory authority has physically inspected the manufacturer to a GMP standard equivalent to that used by the TGA.

  • We do not accept a regulatory authority's evidence as a result of their own desktop-based assessments.

In many cases, the MRA and CV pathways are unavailable because other countries have different regulatory frameworks and GMP standards. For example:

  • biologicals, human blood and blood components and Haematopoietic Progenitor Cells (HPCs) as Australia has its own manufacturing standard for these product types. However, where the manufacturing site performs only sterilisation of these products, the MRA or CV pathways may be used
  • some complementary and listed medicines, including sunscreens. These may not be regulated as medicines in other countries.

TGA on-site inspection

If the manufacturer produces one of the product types not available to the MRA or CV pathways, or if no acceptable evidence from a recognised regulatory authority is currently available, you may apply to obtain a GMP clearance through the TGA on-site inspection pathway.

  • You cannot cancel a TGA on-site inspection by submitting a desktop assessment via the MRA or CV pathways if we have confirmed the inspection dates with the manufacturer and travel arrangements have commenced.

Important - The TGA has the right to inspect an overseas manufacturing site regardless of what other evidence you supply - for example, we may:

  • have identified issues during the CV assessment
  • have received other regulatory information or have concerns about the manufacturer's level of compliance
  • be inspecting an adjacent facility.

If you were not using the manufacturer at the time the inspection was scheduled, you may still apply for a GMP clearance via a desk top process. Please refer to TGA certificates in the Other types of evidence section.

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