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Australia: TGA Clarifies Special Access Scheme Adverse Event Reporting Requirements

Friday, January 05, 2018: The Therapeutic Goods Administration (TGA) of Australia has updated its guidance on the use of unapproved therapeutic goods. TGA’s changes clarify the adverse event reporting requirements for drugs made available to patients under its special access scheme.

Australia created the scheme to provide treatments for patients for whom all approved products are clinically unsuitable. Several pathways exist to enable doctors to access such drugs for their patients. All the pathways are covered by adverse event reporting requirements, but these were inadequately elucidated in the original guidance. TGA has now addressed this shortcoming.

The revised guidance is more strongly worded. The original text “encouraged” sponsors to report “all serious unexpected adverse events.” In the latest text, TGA has replaced “encouraged” with “expect” and dropped “serious” from the description of the adverse events it wants sponsors to report.

TGA has made similar changes to its description of the timelines for reporting these events. The older text said sponsors should “ideally” file reports about fatal or life-threatening outcomes within seven calendar days. In the revised guidance, TGA states sponsors “should” meet this deadline and others described in the text.

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