Biovigilance responsibilities of sponsors of biologicals

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Australian requirements and recommendations

13 December 2017

This guidance concerns proposed amendments to the Therapeutic Goods Act 1989. The proposed amendments have not yet become law and may be subject to change. The purpose of this guidance is to make you aware of these proposed changes if/when they take effect.

Disclaimer

The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 proposes amendments to the Therapeutic Goods Act 1989 (Act). The proposed amendments have not yet been passed by Parliament and may be subject to change. A link to the Bill can be found at: Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017.

Amendment regulations to support a number of measures in this Bill are proposed, but have also not yet become law as they rely on the Bill first being in place and on the Governor General's approval of the regulations. The purpose of this guidance is to inform stakeholders about these proposed changes. While reasonable care is taken to ensure that the information is an accurate description of the proposed changes, TGA does not guarantee or warrant the accuracy, reliability, completeness or currency of the information or its usefulness in achieving any purpose. To the fullest extent permitted by law, including but not limited to under s 61A of the Act, TGA will not be liable for any loss, damage, expense or cost incurred or arising as a result of any use or reliance on this information.

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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