Consultation: Reporting requirements for safety issues - Proposed changes to the 'Pharmacovigilance responsibilities of medicine sponsors: Australian recommendations and requirements'

Overview

The TGA is requesting feedback from key stakeholders on proposed changes to the Pharmacovigilance responsibilities of medicine sponsors: Australian recommendations and requirements guidance document (the PV Guidelines), with respect to the definition of, and reporting requirements for, safety issues.

The aim of these changes is to support timely responses to new safety information by the TGA. The proposed changes to the PV Guidelines are not intended to lessen the current requirements for reporting of safety issues, but to better define which issues are to be notified urgently, and to allow more time for the appropriate review of all other safety issues. These changes should increase the quality of notifications and enable the TGA to act on all safety issues in a timeframe proportionate to the risk to public health.

Why your views matter

By responding to the survey below, you are assisting the TGA in ensuring that the guidance relating to safety issues in the PV Guidelines is clear and the reporting requirements are suitable and practicable for medicine sponsors to implement.

Please read the consultation paper below prior to completing the survey.

What happens next

Following consideration of responses, the final revised version of the PV Guidelines will be republished as version 3.0. This is expected to occur in early 2023.