Australia's TGA Reduces Timelines for GMP Clearance Applications

Regulatory NewsRegulatory News | 03 September 2015 |  By 

Although the Australian regulator admits that it's still seeing extended processing timelines, the Therapeutic Goods Administration (TGA) says that it has cut the average time taken to evaluate a mutual recognition agreement (MRA) GMP clearance application by about 10 weeks since June.


Back in May 2011, TGA began mandating that Good Manufacturing Practice (GMP) clearance applications were required for all medicines supplied in Australia. As part of that process, TGA put out two guidance documents for sponsors who rely on overseas drug manufacturers in order to provide more information about what is an acceptable form of evidence to confirm GMP compliance, and how to submit such an application.

TGA lays out a number of requirements in the guidance and said it expects sponsors to "remain vigilant" in ensuring the regulatory compliance of the overseas manufacturing sites they use.


Between 2011 and 2015, the number of overseas manufacturers increased dramatically and TGA says the number of GMP Clearance applications has more than doubled. In 2014-15 a total of 5,384 applications were received, which compares with 4,222 applications in 2013-14 and 2,418 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)," the TGA said.

And now TGA is reaping the rewards of those efforts as the average time taken to complete an MRA GMP Clearance application has fallen from 16 weeks in June 2015, to an average of six weeks as of 14 August 2015.


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

"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," TGA says.



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