New international standard to improve safety of medicines

News 21/01/2015

New EMA guide will help industry and regulatory authorities to implement changes

The European Medicines Agency (EMA) has published a PDF icon guide to support the implementation of a new international standard for the safety monitoring of medicines in the European Union (EU). The so-called ISO ICSR standard improves the reporting of suspected side effects of medicines in Individual Case Safety Reports (ICSRs). The use of the new international standard will take effect on 1 July 2016.

ISO ICSR aims to establish the same format for the reports on individual cases of suspected side effects in patients due to a medicine across the world. It also is expected to include better information on medicines that might be associated with an adverse drug reaction and on the therapeutic uses of those medicines. In addition, the standard also strengthens personal data protection in the records of ICSRs collected by pharmaceutical companies and regulatory authorities.

This will improve the quality of data collected, and increase the ability to search and analyse them. Regulatory authorities will be able to detect and address safety issues with medicines more quickly, and therefore better protect patients.

The new guide developed jointly by EMA and the Heads of Medicines Agencies (HMA) will be of interest to pharmaceutical companies and medicines regulatory authorities in EU Member States and will support them to prepare for the use of the standard. The guide specifically defines 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 finalisation of the guide is a major step in EMA's preparation for an enhanced EudraVigilance system, the European database of all suspected adverse reactions reported with medicines authorised in the European Economic Area (EEA), as required by the EU pharmacovigilance legislation.


  • This guide is based on the ICH E2B (R3) guideline and the corresponding ISO ICSR standard as referred to in Article 26 of the Commission Implementing Regulation (EU) No. 520/2012. The guide will apply with the use of the ISO ICSR standard as of 1 July 2016.
  • The next step for the development of the EudraVigilance system based on the new ISO ICSR standard and related EU guide are further outlined in the News bulletin for pharmacovigilance programme update - Issue 2.

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