FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

TGA Issues Guidance on New Testing Requirements

April 9, 2019
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Australia’s Therapeutic Goods Administration issued guidance to help sponsors comply with “minimum” drug quality requirements under a new standard that went into effect on March 31.

The new standard, Therapeutic Goods Order 101, requires drugmakers to test their pills, capsules and tablets for dissolution, shelf-life and other quality standards—but gives sponsors the option of following either international guidelines in drug monographs or Australia-specific requirements.

The order applies to tablets, capsules or pills that are listed on the Australian Register of Therapeutic Goods (ARTG). Products listed as “export only” don’t have to comply with TGO 101.

Sponsors must test for a drug’s dissolution if it’s a modified-release tablet or capsule, if a tablet or capsule contains 100 micrograms or more of folic acid, or if it’s following Australian-specific rules, TGA says.

Drugmakers won’t be required to test each batch if, for example, they can prove that there aren’t any organic solvents in any part of the manufacturing.

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