Impending Deadline – TGA Pharmacovigilance Risk Assessment Survey

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Oct 27, 2022
1 min read

On 17 October 2022, the TGA indicated its Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is open for completion.

In its guidance dated 17 September 2017, ‘Pharmacovigilance inspection program: Guidance for medicine sponsors’, the TGA detail:

“[the PVIP] aims to strengthen and broaden the TGA's post-market monitoring activities and protect public health by ensuring the continued safety of medicines”.

As to the scope of pharmacovigilance inspections, the TGA emphasise:

“Inspections assess the appropriateness and compliance of your pharmacovigilance system in line with the Pharmacovigilance guidelines”.

Possible TGA inspection review areas are listed here.

In its recent article, the TGA stressed sponsors with medicines “included in the Australian Register of Therapeutic Goods (ARTG) should complete this survey”.

Significantly,

Care should be taken in survey completion as only one attempt is allowed.
Non-completion will result in the TGA assigning the “highest survey risk score”, culminating in a higher priority for inspection.
The survey must be completed online.

The survey consists of 24 questions covering topics, including:

Medicine type (over the counter, prescription, vaccine, generic, listed).
Proportion of the sponsor’s supplied medicine included in Schedule 4 or 8 of the Poisons Standard (SUSMP).
Recent sponsor acquisitions of ARTG-included medicines.
Pharmacovigilance systems (including changes).
Post-market activities.

The survey completion deadline is 18 December 2022.

Komply are available to help medicine sponsors complete the survey, and in other matters relating to pharmacovigilance.

Komply advises and assists clients in end-to-end quality assurance, registration, regulatory, compliance, and commercialisation matters for organisations in pharmaceutical and biotechnology industries.

1 Comment

Kristie Vanhoy Vanhoy

Mar 21

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