Biovigilance responsibilities of sponsors of biologicals

Australian requirements and recommendations

13 December 2017

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All sponsors of products regulated as biologicals under the biologicals framework are required to:

  • Report serious threats to public health and serious and near serious adverse events related to the biological within the regulatory timeframes (see Reporting requirements)
  • retain records pertaining to the reporting requirements and safety of the biological (see Record-keeping requirements)
  • ensure that any request from the TGA for the provision of additional information related to the biological is answered fully and within the specified timeframe

In order to achieve this, sponsors should have a robust biovigilance system in place.

Reporting requirements for biological adverse events: a summary
Adverse event Method of reporting Reporting timeframe[*]

Serious threat to public health

An event or occurrence that represents a serious threat to public health

In writing to:

≤ 48 hours

Serious adverse event

An event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the biological or another person

A number of forms and methods are available: electronic structured data preferred ≤ 10 calendar days

Near serious adverse event

An event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the biological or another person

A number of forms and methods are available: electronic structured data preferred ≤ 30 calendar days
Recalls, quality defects and contaminated or counterfeit biologicals

Human blood & tissues recall report form

or email:

with the least possible delay

*Timeframes are in relation to when the sponsor becomes aware that there is an issue for which there is a reasonable possibility of causal relationship.

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