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Target processing timeline for MRA GMP clearance applications

24 April 2017

The TGA has experienced a significant increase in the total number of GMP Clearance Applications, from approximately 2500 applications in 2010-2011 to more than 5600 applications in 2015-2016. This placed significant pressure our staff and impacted on our target timelines.

In June 2015, we started gathering data about total processing times (from the date payment is receipted to the date GMP clearance is issued) for GMP clearance applications for manufacturers located in countries with which Australia has Mutual Recognition Agreement (MRA GMP clearance applications). We provided regular updates on the TGA website (MRA GMP clearance application processing timelines).

We have reduced the backlog and processing timelines for MRA GMP clearance applications and have maintained average processing times of less than six weeks since August 2016.

Our previous target timeframe was 15 working days. Despite the improvements we have made in our GMP clearance processes, we will not be able to commit to a target of 15 days. We are therefore revising our target timeframe to 30 working days because our experience over the past seven months shows that we can commit to this timeframe. It should be noted that most applications are processed in less than 30 working days and we will continue to aim for the shortest possible processing time for each application.

The revised target time will provide industry with predictable processing timelines, irrespective of fluctuations in application volume or available resources. We will continue to monitor our processing times and application volumes and proactively engage with industry, via the TGA-Industry Working Group on GMP, where there are any risks to our target times.

Please note that we will not be able to commit to the target time of 30 working days where:

  • a sponsor has requested the TGA to liaise with other regulators to obtain the GMP Certificate; or
  • we need to seek additional information or clarification from the applicant; in particular if input from the overseas manufacturer(s) is required.