FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Australia Hikes GMP Clearance Fees

June 6, 2019

Drugmakers in Australia will soon be subject to higher GMP clearance fees, the Therapeutic Goods Administration (TGA) announced.

Starting July 1, compliance verification and application processing fees will go up in price, after being approved but postponed in June of last year following pushback from Australia’s manufacturers, industry groups and others.

Compliance verification fees will increase from AUD$2,070 ($1,432) to  AUD$2,480 ($1,716) while application processing fees will increase from AUD$400 ($277) to AUD$650 ($450).

Additionally, a reinstatement fee goes into effect on that date for sponsors who have allowed their GMP clearance to lapse beyond the 30-day limit. Sponsors seeking reinstatement or extension will be charged an AUD$1,180 ($815) GMP clearance reinstatement fee, TGA said.

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