FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Drugmakers Object to TGA Proposals for Provisional Approval Pathway

Sept. 13, 2017
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Several drugmakers raised objections to proposed data requirements from Australia’s Therapeutic Goods Administration.

The TGA’s proposal would set up a provisional approval pathway that would allow companies to reduce the time it takes for patients to access promising drugs. Major drug companies including AbbVie, Johnson & Johnson, Roche and Sanofi all pushed back against the requirement that applications feature “comprehensive quality and non-clinical safety modules that fulfil TGA’s mandatory data requirements.”

The requirement is impractical because in many cases drug manufacturers may not have complete data at that point in the process, according to a statement from Pfizer. Companies also expressed opposition to the proposal to have provisional registrations lapse after two years, saying the renewal process would be too much of a burden.

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