The European Medicines Agency (EMA) has published a new guide, “ISO ICSR,” supporting a new international standard for the safety monitoring of medications in the European Union. The goal is to improve how suspected medication side effects are reported in Individual Case Safety Reports (ICSR). ISO ICSR was jointly developed by EMA and the Heads of Medicines Agencies (HMA).
In the United Kingdom, the adverse drug reaction reporting system is called Yellow Card Scheme, through which both patients and healthcare professionals can report suspected medication reactions to regulatory authorities. “ISO ICSR seeks to harmonize the reporting system so that the ICSRs of a particular medicine can be analyzed across the world in a comparable manner,” according to TRAC, a regulatory affairs consulting firm in Europe. “The major developments will include changes to the format and content of the ICSR, to improve the quality of data collected, and defining the electronic transmission process of ICSRs, to aid speed of analysis. The standard also strengthens personal data protection. These measures will ensure regulatory authorities are equipped to identify and act on safety issues promptly and therefore increase patient protection.”
The publication of ISO ICSR is a move toward the EMA’s goal of an improved EudraVigilance system, which is the data management system and processing network used for the evaluation and reporting of suspected adverse drug reactions. The new international standard will become effective July 1, 2016.