Mandatory use of international standard for the reporting of side effects to improve safety of medicines

15 January 2020

At its December 2019 meeting, EMA's Management Board agreed to the mandatory use of a consistent international format, the ISO ICSR format, for reporting individual cases of suspected side effects in patients across the world. This follows a recommendation from EMA’s safety committee (PRAC) in October 2019. The use of the new international standard will become mandatory as of 30 June 2022 for all reporting to EudraVigilance, the European database of suspected side effects with medicines authorised in the European Economic Area (EEA).

The ISO ICSR standard is based on the ICH E2B(R3) modalities for the reporting of suspected side effects of medicines in individual case safety reports (ICSRs). Compared to the older reporting formats it improves the quality of data collected and increases the ability to search and analyse these data. This will better support regulatory authorities and companies to detect and address safety issues with medicines and therefore protect patients. In addition, the ISO standard strengthens personal data protection in the records of ICSRs collected by regulatory authorities and companies. 

A European Union individual case safety report (ICSR) implementation guide, jointly developed by EMA and the Heads of Medicines Agencies (HMA), was published in 2015 to help pharmaceutical companies, sponsors of clinical trials and medicines regulatory authorities in EU Member States prepare for the use of the new 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 also assists software providers and IT developers in the development of pharmacovigilance and safety databases.

Targeted communication to concerned stakeholders will follow in due course.

Note:

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.