EMA REPORT ADVISES ON ISO GLOBAL SIDE-EFFECTS MONITORING STANDARD
February 8th, 2015
A NEW international standard for the monitoring and reporting of suspected side effects of medicines has been explained by a new European Medicines Agency (EMA) guide. The standard will come into use from July 2016, and explains how such problems should be noted in individual case safety reports (ICSRs). It has been developed by the International Organization for Standardization (ISO). It aims to establish the same format for the reports on individual cases of suspected side effects in patients worldwide. The aim is to improve information on medicines potentially ...
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