Report advises on ISO global side-effects monitoring standard

Published: 17-Feb-2015

This standard will come into use from July 2016


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 Organisation for Standardisation (ISO). It hopes 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 associated with adverse drug reactions and on the therapeutic uses of those drugs.

The standard also strengthens personal data protection in ICSRs collected by pharmaceutical companies and regulatory authorities. EMA said this 'will improve the quality of data collected, and increase the ability to search and analyse them'. Regulatory authorities should be able to detect and address safety issues more swiftly, it argued.

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