After many years of planning, on 22nd November 2017 the EMA’s EudraVigilance system started accepting ICSRs submissions in the E2B R3 format. This was one amongst many changes made to EudraVigilance on this date, but implementation of R3 is certainly one of the most significant milestones. The switch from R2 to R3 is not simply a technical format change, but has potential upstream and downstream effects on case processing and other PV activities. Although there will be expected challenges in transitioning to a new ICSR format, there may also be unexpected benefits.

At Adis Pharmacovigilance we are pleased to announce that we have recently completed our transition to be able to capture data in the new R3 format, with capabilities to deliver E2B XMLs as R3 or converted R2. Being a literature monitoring service provider, one of the key benefits is that the comprehensive fields offered by R3 allow for greater granularity in structure of the data, which we believe will translate to increased transparency and ease of case review and assessment by our clients. Of course an increase in the number of fields potentially increases the resource required for data entry and, as with implementing any change of this magnitude, this requires investment in system development and staff training.  But with time, the task of ICSR data entry may become quicker due to familiarity with the fields and also expedited decision-making on how to best structure the data. One of the downsides of R2 was the lack of sufficient fields to cover different scenarios, leading to either a square-peg-in-a-round-hole approach or else leaving out the relevant data completely. But with R3 there are options to structure more complex data such as medication errors, to use MedDRA codes for test results, to code drug-device combinations and to capture ‘null flavours’.

Given the widespread application and interplay of EudraVigilance for the flow of ICSRs between MAHs, HAs and the EMA, this means that most pharmaceutical companies and service providers should now be ready to handle R3 messages, at least to some extent.  We recently sent out a short survey to our global readers to find out: how ready is your company? Thanks to all who responded; the winner of the prize draw has been notified.

As expected, we found that the majority of companies are planning to transition to the new format at some point, and in fact most were ready to accept R3 in their systems in line with the EMA’s date of 22nd November. However, implementing the capability to create ICSRs in R3 lags behind this timeline, with most companies planning to transition in Q1 or Q2 2018. This reflects our experience – most of our clients can now either accept R3 inputs or have a converter tool to downgrade R3 to R2. Also we have seen that for many, software upgrades are being introduced in a phased approach which means readiness to submit in R3 is planned for mid-2018.

We also asked our readers about the potential impact of this significant change. The majority felt that the use of R3 would likely increase their resource requirements, but that seemed to be the only negative change expected. Overall, most expected the change to have a positive impact on their organisation. As outlined, the improved granularity of data capture will surely increase the efficiency in reviewing cases as they are processed. But the benefits are likely to extend beyond case processing to other PV activities that are heavily reliant on good quality structured data, particularly signal monitoring. Furthermore, the new format will eventually align with other ISO standards, which again lead to better quality and more structured data, and potentially allow integration with other systems such as electronic health records.

So far, the transition seems to have been relatively smooth for most, but it is likely a case of ‘time will tell’, since the majority of companies are yet to move into the phase of E2B R3 submissions. We would expect a need for additional co-operation and collaboration in the industry to determine how best to use the new format as experience in R3 use grows. However, hopefully all are in agreement that overall this change is a positive step forward for pharmacovigilance and ultimately patient safety.

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5 thoughts on “E2B R3: the countdown is over

    1. Thanks for your comment. The EMA were ready to accept E2B in the R3 format from 22nd November 2017 when they implemented their system changes. The Adis Pharmacovigilance service implemented the R3 format in mid-December.

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