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

On 15 January 2020 the EMA management board announced the confirmation of the mandatory use of the ISO Individual Case Report standard based on ICH E2B(R3) modalities and related ISO standard terminology.

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.

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