The TGA are seeking feedback, closing 5 December 2022, on proposed changed to Safety Reporting Requirements as described in the Pharmacovigilance responsibilities of medicine sponsors: Australian recommendations and requirements guidance document (the PV guidelines).
Please ensure your officers responsible for Pharmacovigilance receive this technical alert
The intention of the proposed changes is stated to increase the quality of notifications, enabling the TGA to act on all safety issues in a timeframe proportionate to the risk to public health. The TGA also state that the aim is not to lessen the current requirements for reporting of safety issues, but to better define which issues are to be notified urgently by sponsors, supporting timely responses to new safety information by the TGA.
This technical alert provides information for members on key aspects of the proposed changes to the PV Guidelines, including related documents and resources.