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Australian pharmacovigilance requirements and recommendations for medicine sponsors

12 November 2013

The revised pharmacovigilance document came into effect on 10 November 2012 with the Therapeutic Goods Amendment Regulation 2012 [No. 3]. The date of effect was delayed in 2011 due to revisions to the document to clarify certain recommendations. The amended document has been restructured to clearly differentiate between mandatory reporting requirements and information provided as guidance to assist sponsors to meet reporting requirements. The document has been renamed to reflect these amendments, and is now titled the Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines ('the pharmacovigilance document').

Further guidance has been included on topics such as pharmacovigilance systems, the information that sponsors should seek for inclusion in reports of adverse reactions, and how to ensure that only valid reports of suspected adverse reactions are submitted to the TGA. Sponsors of medicines are encouraged to become familiar with the new pharmacovigilance document and to follow the guidance provided.

Changes to the requirements for sponsor reporting

Sponsors of all medicines on the Australian Register of Therapeutic Goods (ARTG) are now required to comply with the new pharmacovigilance document. This includes notifying the TGA using the Client Details form of the name and contact details of the nominated pharmacovigilance contact person responsible for fulfilling the sponsor's reporting requirements.

There are no changes to reporting requirements for sponsors of prescription medicines, however sponsors of other medicines on the ARTG are now expected to routinely report serious adverse reactions within 15 calendar days, as opposed to all adverse reactions or similar experiences as soon as practicable after becoming aware of them. Requirements are summarised in the table below.

Summary table of pharmacovigilance reporting requirements for sponsors of registered medicines (prescription and over-the-counter) and listed medicines*
Report type Method/format of reporting Reporting timeframe
Serious adverse reaction reports Blue card/CIOMS form/E2B reports ( reporting form < 15 calendar days
Significant safety issues In writing to the Post-market Surveillance Branch, preferably via facsimile or email < 72 hours
Non-serious adverse reaction reports As line listings or in requested format If requested by the TGA, within the requested timeframe, or in Periodic Safety Update Report (PSUR) if one is required

*For more information please refer to the pharmacovigilance document.

Medicines not on the ARTG

In general, reports of adverse reactions generated during clinical trials should be handled according to the advice issued by the TGA in July 2000 entitled Notes for Guidance on Clinical Safety Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95). Annotated with TGA Comments.

  • Reports in accordance with this guideline for clinical trials should be sent to the Experimental Products Section.
  • Further information can be obtained by calling 02 6232 8101.

Reports of adverse reactions of unapproved medicines outside of clinical trials, should be through the normal ADR reporting mechanisms.

Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines