FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

TGA Scraps 15-Day GMP Clearance Timeline, Expands to 30 Days

May 5, 2017
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Australia’s Therapeutic Goods Administration is abandoning its goal of 15-day timelines to process GMP clearance filings from overseas manufacturers.

TGA has aimed for the 15-day turnaround for over a decade, but says its application volume has grown too large in recent years to realistically achieve the target. Since 2011, applications have more than doubled to 5,600.

The new target turnaround time is 30 working days. But TGA says it can’t commit to a 30-day timeline in all cases. For example, it will not apply when a sponsor asks the agency to collaborate with other regulators to obtain a GMP certificate, or when officials must obtain further information or clarifications from the applicant.

In February, the TGA announced a proposal to ease requirements for access to unapproved drugs, which would save officials from having to process thousands of applications for access to such drugs.

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