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Australia: TGA Resists Industry Pressure to Change Adverse Event Reporting Timelines

Wednesday, December 13, 2017: Australia’s Therapeutic Goods Administration (TGA) has finalized its timelines for reporting adverse events involving biologicals. The timelines are unchanged from draft guidance published last year that was criticized by companies including Pfizer for giving sponsors too little time to act.

Under the guidance, companies have 48 hours to inform TGA of events deemed a serious threat to public health. In the event of serious and near-serious adverse events, companies have 10 and 30 days to report, respectively. The reporting timelines for "recalls, quality defects and contaminated or counterfeit biologicals" are tighter still. TGA wants to hear of such events as soon as possible.

Industry pushback against the timelines centered on the divergence from those applied to other medicines. Manufacturers of small molecules and other more conventional therapeutics have 72 hours to inform TGA of serious threats to public health and 15 days to report serious adverse events.

In establishing timelines for biologicals — products based on human cells or tissues or live animal cells, tissues or organs — TGA has looked to medical devices, not drugs, for inspiration. The timings set in the biological guidance therefore follow those established for devices. TGA thinks this is the right approach given its belief in the similarities between biologicals and medical devices.

While TGA has stood firm on the timelines, it has adapted the guidelines in response to some of the other feedback it received during last year’s consultation. The current version gives a far fuller explanation of what it means when it states the biovigilance contact person must be "permanently and continuously available."

At minimum, the contact person should be available on weekdays during Australian east coast business hours. Companies should have a backup contact person to cover for absences. Other TGA clarifications allay industry concerns about the burden of complying with the recommendations.

"Please note this means the person is contactable when required, e.g. by phone, and not necessarily on-site full-time. Ultimately, sponsors need to be confident that the person responsible for biovigilance can be reached to seek advice in emergency situations," TGA wrote.

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