Updated TGA guidance: Sponsor Pharmacovigilance responsibilities and obligations

The TGA has made changes to  pharmacovigilance expectations for sponsors following consultation on Proposed changes to Pharmacovigilance responsibilities of medicine sponsors: Australian recommendations and requirements.

There will be a 6-month implementation period, beginning Tuesday 1 August 2023, and concluding on Wednesday 31 January 2024, during which adoption of the changes included in the updated guidelines  are strongly encouraged, but not mandatory and will not be inspected against. Sponsors are encouraged to review the new guidance closely to ensure pharmacovigilance systems become aligned with the new system.

This technical alert provides more information for members, including a summary of consultation outcomes, a comparison between the previous and new Pharmacovigilance guidance, and details of a series of upcoming TGA webinars, which will outline and explain the changes to the Pharmacovigilance Guidelines.

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