Francesca Spera -

The new draft guideline on Specific Adverse Reaction Follow-up Questionnaires (AR FUQs) is open for public consultation until February 9th, 2024. This guideline has been issued to provide a framework for the use and implementation of these questionnaires as part of risk management in routine pharmacovigilance activities.

The aim is to provide recommendations on the appropriate timing and methodology for using Specific AR FUQs, as well as to enhance the comprehensiveness of information in pharmacovigilance by using forms and questionnaires to collect missing data on reported adverse reactions that were not initially provided by the reporter and that may have an impact on the balance of benefits and risks of a product or have implications for public health. The missing data can include important identified risks, significant potential risks and any other information that is crucial for evaluating safety concerns.

Specific AR FUQs are formulated by Marketing Authorization Holders (MAHs) at the request of National Competent Authorities (NCAs) and do not intend to alter or modify the internal policy for FUQs of the MAHs. The content of Specific AR FUQs should focus on collecting missing data related to the safety concerns and should be prefilled with available information to avoid duplication. The format of the Specific AR FUQ should follow the recommendations outlined in GVP Module V and GVP Module VI.

In the event that a medicinal product requires a Specific AR FUQ but does not have a Risk Management Plan (RMP) in place, the questionnaire can be associated with a safety concern identified or followed up in the Periodic Safety Update Report (PSUR).

If there is already an RMP in place, the Specific AR FUQ for the relevant safety concern should be included in the RMP.

RPN constantly monitors the EMA websites in order to stay up to date on pharmacovigilance requirements and recommendations and is available to provide full support for pharmacovigilance activities.

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