Insights

EMA Adopts a Guidance Concerning Periodic Safety Update Reports

On April 6, 2017, the European Medicines Agency ("EMA") issued new guidance and recommendations concerning periodic safety update reports ("PSURs") of nationally authorized medicinal products. These recommendations form part of the EMA's commitment to ensure continuous improvement of safety monitoring of medicinal products in the EU.

PSURs are reports submitted by marketing authorization holders that evaluate, on the basis of available safety clinical data, the benefit-risk balance of a medicinal product at a defined time following its authorization. The EMA uses the information contained in the PSURs to determine whether new risks exist and if the benefit-risk balance of a concerned medicinal product should be updated. The EMA can decide to conduct further investigations or decide to take measures to protect public health. Since 2015, the PSURs of medicinal products containing the same active substance or the same combination of active substances have been assessed jointly by the EMA in a so-called periodic safety update report single assessment ("PSUSA") procedure.

In order to clarify the PSUSA procedure, the EMA has issued an "Explanatory Note to GVP Module VII" and guidance entitled "Q&A on PSUSA: Guidance document for assessors." The Explanatory Note addresses issues encountered by marketing authorization holders, and the Q&A is intended to help assessors evaluate PSURs in a consistent way.

With these two documents, the EMA seeks to encourage the PSUSA procedure in order to streamline the evaluation of PSURS for medicinal products containing the same active substance or the same combination of active substances and, thus, allow consistent safety information to be issued for a concerned medicinal product.

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