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Jan 28
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New industry standard becomes effective in June, 2022

In their December meeting, the European Medicines Agency (EMA) announced their intention to act on the Pharmacovigilance Risk Assessment Committee‘s (PRAC) recommendation to improve reporting obligations, in relation to EudraVigilance, with the implemented use of the following becoming mandatory on 30th June, 2022:

– The ISO Individual Case Safety Report (ICSR) standard as referred to in Article 26(2)(a) of the Commission Implementing Regulation (EU) No 520/2012 and the modalities on how to use this ISO ICSR standard defined in the ICH E2B(R3) documentation, and

– The ISO terminology on pharmaceutical dose forms and routes of administration referred to in Article 25(1)(f) of Commission Implementing Regulation (EU) No 520/2012.

This recommendation and subsequent action resulted from the recognised need to define a specified date for the mandatory use of the ISO ICSR format, with the intention of strengthening the pharmacovigilance function through heightening data quality and analytical capabilities within EudraVigilance; in conjunction with utilising an internationally agreed format and industry standardised terminology, to help pharmaceutical companies comply with their pharmacovigilance obligations throughout the European Union.


For further background on the EMA’s announcement, please refer to their formal release.


The EMA have also outlined their intention to continue providing both face-to-face training, online training and webinars, as means of assisting pharmaceutical companies and industry professionals, to best prepare for the technicalities encompassed with this new industry standard; in addition to the EMA and the Heads of Medicines Agencies (HMA) scheduling the release of a revised edition of the EU ICSR Implementation Guide for Q4 2020 – utilising user experience and stakeholder feedback to build upon the existing 2015 guide.

A further 2020 course programme is currently scheduled for publication in February 2020, and can be accessed via the EudraVigilance training and support web-page – along with all future updates.

PharSafer will provide further updates to information in due course.

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