Biovigilance responsibilities of sponsors of biologicals

Australian requirements and recommendations

13 December 2017

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Your record-keeping requirements

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.

You must retain records pertaining to the reporting requirements and safety of your biological (section 5 of the Therapeutic Goods (Biologicals - Conditions of Inclusion in Register) Determination 2017). Information relating to biovigilance activities and the safety of the biological include, but is not limited to:

  • all adverse event reports (serious, near-serious and non-serious)
  • information surrounding serious threats to public health
  • special situation reports including, but not limited to, reports:
    • from post-registration studies
    • from post-marketing initiatives
    • of exposure during pregnancy and breastfeeding
    • of use in paediatric or elderly populations
    • of lack of efficacy
    • of quality defect issues
    • of transmission of infectious agents
    • of overdose, abuse, off-label use, misuse, medication error or occupational exposure
    • of non-serious adverse reactions and reactions occurring overseas
    • relating to suspended or discontinued products
  • reference safety documents and non-valid reports containing biological-event pairs

These must be kept for as long as the product is approved for inclusion in the ARTG and for a period of 10 years after removal from the ARTG.

General safety information on your biological should also be retained for as long as the product is approved for inclusion in the ARTG. This includes, but is not limited to:

  • ongoing monitoring activities
  • PSURs
  • literature reviews
  • contracts with biovigilance providers
  • documentation regarding changes to reference safety information
  • biovigilance procedural documents
  • biovigilance training documents

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