European medicine agency guidance to the EU/EEA regulatory medicines network on when and how to use specific adverse reaction follow-up questionnaires (Specific AR FUQs) in routine pharmacovigilance activities.
The completeness of information in Individual Case Safety Reports (ICSRs) is essential in many pharmacovigilance assessments. However, the information available in these reports is often limited and may lack essential data that would allow for better characterization of the reported adverse reactions. To address this issue, forms and questionnaires are commonly used to collect additional information when initial reports are incomplete. These include general follow-up questionnaires (FUQ)and Specific AR FUQs.
The document identifies three main directions:
- providing general guidance on when and how to use Specific AR FUQs,
- guidance for MAHs on developing Specific AR FUQs,
- and considering discontinuation and removal of Specific AR FUQs
The content of a Specific AR FUQ should focus on collecting the missing data of main importance for assessing the safety concerns in question and should be prefilled with available information to avoid requesting the primary source to repeat information. A Specific AR FUQ should not be extensive and its completion by the reporter should be easy to minimize the burden on reporters and to avoid discouraging future spontaneous reporting.
Takeaway: Overall, in addition to existing GVP guidelines, this guidance provides a framework for the use and implementation of Specific AR FUQs as part of risk management in routine pharmacovigilance activities to improve the completeness of information in pharmacovigilance.
To facilitate knowledge sharing, a tool is being developed to list and publish approved Specific AR FUQs.
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