EMA publishes guidelines on Specific AR FUQs
On 28 November 2024, the European Medicines Agency (EMA)’S Pharmacovigilance Risk Assessment Committee adopted new guidelines on the use of specific adverse reaction follow-up questionnaires (Specific AR FUQs) in routine pharmacovigilance activities. The guidelines, set to take effect on 1 February 2025, outline when and how to use Specific AR FUQs, recommending their use for safety concerns that may impact a product's benefit-risk balance. The document provides guidance for Marketing Authorisation Holders (MAHs) on developing Specific AR FUQs, as well as considerations for their discontinuation and removal. It also details requirements for the content, format, and dissemination of Specific AR FUQs. The EMA notes that the guidelines do not intend to modify MAHs' internal policies for FUQs.