TGA Issues Risk Survey to Drugmakers Ahead of First Pharmacovigilance Inspections
Australia’s Therapeutic Goods Administration issued a survey to drugmakers asking about their pharmacovigilance activities with the intention of using the responses to prioritize inspections.
Any companies failing to complete the survey will automatically be assigned the highest risk score, the agency said.
The TGA piloted pharmacovigilance inspections in 2015 and 2016 and has issued the survey ahead of the full rollout.
TGA will use survey responses in combination with other risk data to assign companies a risk score that will be used as the basis for prioritizing inspections.