EMA reviews advice on periodic safety update reports (PSURs)

Published: 20-Jan-2015
Regulatory Pharmaceutical

Aims to take account of patient monitoring and side effects to improve safety advice about pharmaceuticals


The European Medicines Agency (EMA) has updated procedural guidance on how pharmaceutical companies should make periodic safety update reports (PSURs) about approved medicines. The aim is to take account of patient monitoring and side effects to improve safety advice about pharmaceuticals. Until now, proposed changes to product information required submission of tracked-changes versions of all national product data covered by a particular PSUR.

Under a new system, piloted by EMA from this month, a simplified approach for reporting such new information can be used.

The new guidance stresses the importance of pharmaceutical companies consulting with EMA over upcoming proposed changes to an approved medicine’s condition of use. This would allow 'optimal planning, identification of procedural issues and handling of overlapping applications,' the Agency said.

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  • EMA European Medicines Agency
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