EMA Updated Questions & Answers on Signal Management

On 15 January 2021 the EMA published revision 4 of the Q&A on signal management.

Signal management is defined in article 107h of Directive 2001/83/EC, article 28a of Regulation (EC) No 726/2004 and chapter III of Commission Implementing Regulation (EU) No 520/2012.

This document addresses a number of questions which stakeholders, in particular marketing authorization holders (MAHs), may have on the management of safety signals. This revision includes update of the requirements for the submission of additional data (question 11).

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