The Therapeutic Goods Administration (TGA) Australia has released a Pharmacovigilance Inspection Program (PVIP) risk assessment survey for sponsors to complete. The TGA is surveying sponsors about their Pharmacovigilance (PV) activities to identify high-priority targets for its new inspection program. Sponsors who fail to complete the survey by 31st March 2018 will automatically receive the highest survey risk score, making them a top target for TGA inspectors.
To verify sponsors are complying with its regulations and ensure the collection of safety and efficacy data, Australia’s TGA is introducing PV inspections. The program was piloted in 2015 and 2016, but is now pushing ahead with a full rollout. A risk-based compliance program, similar to the inspection model used by the Medicines and Healthcare products Regulatory Agency (MHRA), is being adopted.
All sponsors who have at least one medicine included in the Australian Register of Therapeutic Goods (ARTG) are encouraged to complete the survey. The questions in the survey include asking for information such as how many medicines the sponsor markets in Australia and whether sponsors outsource any PV activities, if they audit their providers and how long it typically takes them to submit adverse event reports.
Survey risk scores will be combined with other risk information which is known to the TGA, to help prioritise and schedule pharmacovigilance inspections. The TGA plans to give sponsors six to eight weeks’ notice before they visit, however surprise inspections can be expected. If the agency finds evidence of significant noncompliance on its original visit then they may re-inspect sponsors early.
To view the TGA PV inspection program risk assessment survey, please click here.