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Consultation: Guidance on biovigilance responsibilities of sponsors of biologicals

31 October 2016

This consultation closed on 16 December 2016

The TGA sought comments from interested parties on draft guidance on Biovigilance responsibilities of sponsors of biologicals - Australian requirements and recommendations.

This consultation is related to two concurrent consultations on guidance on risk management plans for medicines and biologicals and the adoption of a European Union guideline in Australia.

Consultation documents

How to access a pdf or Word document


Documents released for consultation on 31 October 2016.

Interested parties responded by close of business 16 December 2016.

Feedback will be released following consideration of submissions. (See 'What will happen').

About the consultation

The regulatory framework for biologicals provides the legislative basis for the regulation of human tissue and cell-derived products and commenced on 31 May 2011. The legislative basis for biovigilance for included biologicals has been in place, but there is currently no guidance available to sponsors of biologicals to assist them in meeting their biovigilance obligations. The consultation paper has been developed to provide this guidance.

The document provides draft guidance for sponsors of biologicals on their biovigilance responsibilities. It sets out requirements and recommendations for detecting and reporting adverse events and serious threats to public health that may arise in relation to the use of any class of products regulated by the Therapeutic Goods Administration (TGA) under the biologicals framework. The guidance is aligned where possible with the TGA guidance for reporting in relation to medicines Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines, however, it uses different terminology owing to differences in the underpinning legislation for medicines and biologicals.


Submissions may be provided on any aspect of the policies or processes outlined in the consultation document.

An overview and copies of submissions received, as well as TGA's responses to the submissions, are available at: Submissions received: Guidance on biovigilance responsibilities of sponsors of biologicals.


Any questions relating to submissions should be directed to the Signal Investigation Coordinator by email or by telephone to the TGA Information Line 1800 020 653.

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
    • seek feedback about how the consultation was undertaken.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
  • More information on consultations and privacy is included in the submission form and on our website.