Regulatory Focus™ > News Articles > 2020 > 1 > EMA: ISO Side Effect Reporting Format Mandatory by Mid-2022

Regulatory NewsRegulatory News
Posted 15 January 2020 | By Michael Mezher 

EMA: ISO Side Effect Reporting Format Mandatory by Mid-2022

The European Medicines Agency’s (EMA) management board last month agreed to make the International Organization for Standardization’s (ISO) individual case safety report (ICSR) format mandatory for suspected adverse reaction reporting to EudraVigilance beginning 30 June 2022.
The format, ISO/HL7 27953-2:2011, is based on the International Council for Harmonisation (ICH) E2B(R3) guideline on data elements for transmission of ICSRs.
“Compared to the older reporting formats it improves the quality of data collected and increases the ability to search and analyze these data. This will better support regulatory authorities and companies to detect and address safety issues,” EMA writes, adding that the ISO format offers stronger personal data protection for patients.
While the ISO ICSR standard is specified in Article 26(2)(a) of the Commission Implementing Regulation (EU) No. 520/2012 on pharmacovigilance activities, ICSRs in the previous ICH E2B(R2) format are currently accepted in EudraVigilance, but must be converted upon receipt to ISO ICSR format.
The issue with converting from the old format, EMA’s management board says, is that “as part of this process, important information is often not available in dedicated data fields and may only be found in case narratives.” This in turn hampers the search and data analysis capabilities of regulators, as well as marketing authorization holders and the World Health Organization’s Uppsala Monitoring Centre, “which have restricted access to case narratives due to data protection.”
In addition to the ISO ICSR format, use of ISO terminology on pharmaceutical dose forms and routes of administration will also be required as of 30 June 2022.
EMA, Management Board Announcement


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy
No data found