EMA publishes guide for pharma companies to support new medicines monitoring standard

22 January 2015

The European Medicines Agency has published its guide to support the implementation of a new international standard for the safety monitoring of medicines in the European Union.

The new standard improves the required reporting of suspected side effects of medicines in Individual Case Safety Reports, and will take effect on July 1 2016.

The standard, called ISO ICSR, aims to establish the same format for the reports on individual cases of suspected side effects in patients due to a medicine globally. The standard strengthens personal data protection in the records of ICSRs collected by pharma companies and regulatory authorities, which will improve the quality of data collected, as well as enable easier search and analysis.

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