EMA Publishes Safety Monitoring Guide

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The European Medicines Agency has published a guide to help industry and regulatory authorities implement safety-monitoring standards.

The European Medicines Agency (EMA) has published a guide on the implementation of the ISO Individual Case Safety Report (ICSR) standard, which improves the reporting of suspected side effects of medicines in ICSRs. The EMA guide was developed, jointly with the Heads of the Medicines Agency, to support pharmaceutical companies and medicines regulatory authorities in EU Member States in preparing for implementation of the ISO ICSR standard. According to EMA, the guide provides “definitions for the electronic transmission process of ICSRs, the format and content of the ICSR, the business rules for report validation as well as classification and data quality principles. It will also assist software providers and IT developers as pharmacovigilance databases are being developed.”

The ISO ICSR standard, which takes effect July 1, 2016, establishes a single format for the reports on individual cases of suspected side effects in patients due to a medicine across the world. The standard also includes adverse drug reaction information and information on the therapeutic uses of those medicines. The standard aims to improve the quality of data by strengthening personal data protection in the records of ICSRs collected by pharmaceutical companies and regulatory authorities.


Source: European Medicines Agency