FDAnews Drug Daily Bulletin

TGA Announces Tougher Rules on Unfinished GMP Applications

Sept. 21, 2017

Australia’s Therapeutic Goods Administration said it will crack down harder on incomplete GMP clearance applications.

The move comes in the wake of a sharp increase in requests for clearance to produce drugs overseas, which have increased 140 percent since 2010. About 60 percent of the applications lack sufficient evidence that production facilities are in compliance with GMPs, the agency said.

Under the new policy, for any application submitted until Sep. 26, the agency will reach out to companies for any unfiled supporting evidence. After that date, incomplete applications will prompt a TGA assessment action.

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