MRA GMP clearance application processing timelines

8 March 2017

Updates: 2017 2016 2015

2017

8 March 2017

For the month of February 2017, the average processing time taken to complete an MRA GMP clearance application was 3.5 weeks. The time taken to complete 90% of MRA GMP Clearance applications was 7 weeks.

We will continue to keep you informed of our progress in reducing MRA GMP clearance application processing times.

9 February 2017

For the month of January 2017, the average processing time taken to complete an MRA GMP clearance application was 4.9 weeks. The time taken to complete 90% of MRA GMP Clearance applications was 8.6 weeks.

We will continue to keep you informed of our progress in reducing MRA GMP clearance application processing times.

2016

5 January 2017

For the month of December 2016, the average processing time taken to complete an MRA GMP clearance application was 3.5 weeks. The time taken to complete 90% of MRA GMP Clearance applications was 5.4 weeks.

5 December 2016

As of 30 November 2016, the average processing time taken to complete an MRA GMP clearance application was 4.3 weeks. The time taken to complete 90% of MRA GMP Clearance applications was 7.4 weeks.

10 November 2016

As of 31 October 2016, the average processing time taken to complete an MRA GMP clearance application was 4.5 weeks. The time taken to complete 90% of MRA GMP Clearance applications was 6.0 weeks.

30 September 2016

As of 27 September 2016, the average processing time taken to complete an MRA GMP clearance application was 4.7 weeks. The time taken to complete 90% of MRA GMP Clearance applications was 6.7 weeks.

5 September 2016

As of 28 August 2016, the average processing time taken to complete an MRA GMP clearance application was 5.0 weeks. The time taken to complete 90% of MRA GMP Clearance applications was 7.1 weeks.

11 August 2016

As of 31 July 2016, the average processing time taken to complete an MRA GMP clearance application was 4.8 weeks. The time taken to complete 90% of MRA GMP Clearance applications was 7.8 weeks.

8 July 2016

As of 7 June 2016, the average processing time taken to complete an MRA GMP clearance application was 6.6 weeks. 90% of the finalised MRA GMP Clearance applications were within 7.5 weeks.

As of 21 June 2016, the average processing time taken to complete an MRA GMP clearance application was 5.3 weeks. The time taken to complete 90% of MRA GMP Clearance applications was 7.2 weeks.

25 May 2016

As of 9 May 2016, the median processing time taken to complete an MRA GMP clearance application was 5.0 weeks and average processing time was 6.5 weeks.

As of 23 May 2016, the median processing time taken to complete an MRA GMP clearance application was 5.3 weeks and average processing time was 8.2 weeks.

6 May 2016

As of 26 April 2016, the median processing time taken to complete an MRA GMP clearance application is 4.1 weeks and average processing time is 8.7 weeks. The TGA is taking a focused approach to clear out MRA GMP clearance applications submitted prior to the introduction of the new work management system to allow better tracking of applications in the future. Finalisation of these applications has contributed to the longer average processing time for the most recent reporting period. We anticipate that as we clear these older applications the processing times will reduce. Currently all outstanding legacy applications are awaiting information from sponsors.

29 March 2016

As of 16 March 2016, the median processing time taken to complete an MRA GMP clearance application is 4.6 weeks and average processing time is 12.4 weeks. The TGA is taking a focused approach to clear out MRA GMP clearance applications submitted prior to the introduction of the new work management system to allow better tracking of applications in the future. Finalisation of these applications has contributed to the longer average processing time for the most recent reporting period. We anticipate that as we clear these older applications the processing times will reduce.

2015

18 December 2015

As of 4 December 2015, the average processing time taken to complete an MRA GMP clearance application has increased from 6 to 9 weeks. The time taken to complete 90% of MRA GMP clearance applications has increased to 27 weeks.

Assessment of all applications taking longer than 11 weeks to finalise found 80% of these applications had awaited submission of supporting evidence during the course of assessment.

We anticipate that processing times will continue to be affected by the festive season and are making plans to return to our recent performance as soon as possible in the new year.

12 November 2015

While extended timelines continue to be experienced, TGA has made significant improvements in processing times for MRA GMP Clearance applications. As of 6 November 2015, we have maintained the 6 week average processing time taken to complete an MRA GMP clearance application. However, further analysis reveals that the time taken to complete 90% of MRA GMP clearance applications has increased from 11 weeks (as at 14 August 2015) to 19 weeks.

Assessment of this anomaly reveals that this is due to a small number of applications processed between 26 October and 6 November 2015 that had been in the system for lengthy periods of time. In all cases these applications were received before mid-June 2015, at which time improvements made to the workflow system came into effect that allow better tracking of GMP clearance applications.

The current average time taken to complete MRA assessments is a result of significant additional efforts by our staff, including overtime sessions. As we reduce the backlog, we will continue to assess processing times to identify an achievable target timeframe for MRA GMP clearance applications.

3 September 2015

We are still experiencing extended processing timelines. However our efforts are having an impact: On 19 June 2015, the average time taken to complete an MRA GMP Clearance application was 16 weeks. By 17 July 2015 we had reduced this to an average of 11 weeks. As of 14 August 2015 this has further been reduced to an average of 6 weeks.

Analysis of the GMP Clearance applications processed shows that 90% of the MRA applications finalised in the week of 12 to 17 June 2015 were completed within 24 weeks of payment receipt, whereas 90% of the applications finalised in the week of 13 - 17 July 2015 were completed within 19 weeks of payment receipt. As of 14 August 2015, 90% of the MRA applications are being completed within 11 weeks of payment receipt.

We will continue our efforts to clear the current backlog of GMP Clearance applications and will provide you with updates on progress.

30 July 2015

The TGA has experienced a significant increase in the number of GMP Clearance applications. In 2014-15 a total of 5384 GMP Clearance applications were received. This compares with 4222 applications in 2013-14 and 2418 in 2010-2011. This has created a backlog of applications and has extended processing times. To address this, we have focused on reducing the largest part of the backlog, namely applications for manufacturers located in countries with whom Australia has Mutual Recognition Agreement (MRA applications).

To allow tracking of our progress on reducing the backlog, we have started gathering data relating to the total processing time (from the date payment is receipted to the date GMP clearance is issued) for each MRA application finalised since mid June 2015.

Although we are still experiencing extended processing timelines, our efforts are having an impact: On 19 June 2015, the average time taken to complete an MRA GMP Clearance application was 16 weeks. By 17 July 2015 we had reduced this to an average of 11 weeks.

Analysis of the GMP Clearance applications processed shows that 90% of the applications finalised in the week of 12 to 17 June 2015 were completed within 24 weeks of payment receipt, whereas 90% of the applications finalised in the week of 13 - 17 July 2015 were completed within 19 weeks of payment receipt.

We will continue our efforts to clear the current backlog of GMP Clearance applications and provide you with updates on progress.

22 May 2015

The TGA has experienced a significant increase in the total number of GMP Clearance Applications, from approximately 2500 in 2010 to more than 4000 in 2014/2015. This has placed significant pressure on TGA's existing resources, as a result of which we are currently not able to consistently meet our target timelines.

To improve TGA's ability to meet demand we are reforming our processes. Our process reforms include the collection of performance data which will enable us to better understand inefficiencies in our processes. This information will be used to inform consultation with stakeholders.

In the interim please ensure that all required information, as prescribed in the Australian Regulatory Guidelines, Good Manufacturing Practice (GMP) Clearance for Overseas Manufacturers, 17th Edition, is provided at time of lodgement, and can be easily identified.

Over the coming months we will be providing further updates on progress on this web site and through the TGA Industry Working Group on GMP.