This member only Technical alert outlines TGA mandatory pharmacovigilance requirements. Not conforming to mandatory pharmacovigilance requirements places members at risk of regulatory action, including infringements, and the TGA have given infringements to some in 2021 and 2022 for not complying with these requirements.
This technical alert also describes best practice pharmacovigilance for practices which might be considered at a TGA inspection of a sponsor as part of the Pharmacovigilance Inspection Program.
This information was disseminated to members in November 2020 and in May 2021.
In addition to the member only alert, a public alert is available for open distribution to all members of industry which describes the mandatory requirements to ensure that all have access to timely reminders for minimum safety compliance requirements which help to uphold industry safety and quality. This public link can be shared.