The TGA is conducting a Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey for medicine sponsors. The survey is now open for medicine sponsors to complete.
Background to the survey
The survey is designed to inform the TGA about the following concerning medicine sponsors and will serve as a tool to help prioritise and schedule pharmacovigilance inspections:
- medicine portfolio,
- pharmacovigilance system,
- inspection history and compliance with Australian pharmacovigilance legislation and guidelines,
Who is the survey for?
Any sponsor who has at least one medicine included in the Australian Register of Therapeutic Goods (ARTG) should complete this survey.
Is this a mandatory survey?
Whilst it does not state whether the survey is mandatory, the TGA makes it clear that medicine sponsors that do not complete this survey will be assigned the highest survey risk score.
What do the survey questions concern/relate to?
The survey questions relate only to your medicines (not medical devices or biologicals) included in the ARTG. This includes all listed, registered and provisionally registered medicines.
Is there a list of questions available to prepare the responses for the survey?
Yes, to help you prepare your responses, the TGA has provided a copy of the survey questions.
Instructions for completing the survey
Included in the instructions for completing the survey are the following important points:
- You must complete and submit your survey responses online using this link.
- This survey must be completed in one attempt only.
- Partially completed surveys will not be recorded and cannot be retrieved for later use.
- Please answer carefully and truthfully as the TGA may ask for evidence of your responses during a pharmacovigilance inspection.
What are the start and end dates of the survey?
Survey start date: 17 October 2022
Survey end date: 18 December 2022
Source: TGA