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GMP clearance guidance update (version 18.3)

27 June 2019

We are continuously making efforts to improve our current processes while keeping the industry informed. As part of that, GMP clearance guidance material has been reviewed to reflect the current processes and provide additional information for sponsors and applicants. We have published an updated version of the GMP clearance guidance (version 18.3) on TGA website. This version includes the following updates:

  • Target processing timeframes for Compliance Verification (CV) applications submitted from 1 July 2019
  • Additional information on prioritisation requests

The previous version of the guidance will be archived and will no longer be accessible.

We strongly encourage you to familiarise yourselves with, and start using the updated version of the GMP clearance guidance.

Enquiries and feedback

The TGA welcomes feedback that helps processes to be improved. We would welcome any feedback you have on the updated GMP clearance guidance.

You can find our contact details at Manufacturing therapeutic goods.