In January 2020, the EMA’s management board announced that the use of E2B(R3) will become mandatory in production as of 30 June 2022. At the moment, a transition phase applies where either E2B(R2) or E2B(R3) messages can be sent. In anticipation of the full production switch in June, the EMA has now announced that E2B(R2) is no longer accepted in Eudravigilance XCOMP (a.k.a. Test). The clock is ticking.
Organizations in the life sciences industry will be required to use a new consistent international format for reporting individual cases of suspected side effects in patients this year.
The ISO ICSR format is based on the ICH E2B(R3) modalities for the reporting of suspected side effects of medicines in individual case safety reports. It is set to change 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.
The aim of the new format is to improve the quality of data collected and support the ability to search and analyze that data to find common trends and issues. This will help regulatory authorities and companies detect and address safety issues with medicines that are for public use.
All organizations and entities in the life sciences and similar industries that operate with licensed products in Europe must use the new standard format.
Be E2B(R3) Ready!
Failing to maintain pharmacovigilance data can result in legal penalties and offences. However, it can be a complicated and costly process that ultimately contributes little to the bottom line. That’s why organizations should find the most cost-effective yet reliable solution to minimize pharmacovigilance costs in preparation for E2B(R3).
To ensure that your organization is E2B(R3) ready before the requirement goes live in June 2022, use EXTEDO’s SafetyEasy PV, the most cost-effective solution for effortless E2B(R3) drug safety compliance. Not only is SafetyEasy PV completely prepared for R3, but it also ensures compliance, readily monitors deadlines and activities, and is easy-to-use with minimal training effort.