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Consultation: Guidance on risk management plans for medicines and biologicals

31 October 2016

This consultation closed on 16 December 2016

Invitation to comment

The TGA sought related to two concurrent consultations for guidance on biovigilance responsibilities and on 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 risk management plans (RMPs) for included biologicals has been in place, but there is currently no guidance available to sponsors of biologicals to assist them in meeting their obligations. The consultation paper has been developed to provide this guidance.

The document is revised guidance on risk management plans for medicines and biologicals. It has been developed from the current guidance on risk management plans for medicines. Where appropriate, reference to biologicals and biovigilance has been added. Also included is a section which details the additional requirements for biologicals based on the European Union requirements for advanced therapy medicinal products (EMEA/149995/2008 (pdf,207kb)). The revised guidance describes the TGA expectations for preparation of risk management plans for Class 2, 3 & 4 biologicals.

Content of submissions

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

See: Submissions received


Any questions relating to submissions should be directed to the RMP Coordinator, Pharmacovigilance and Special Access Branch, 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.