Over recent years there has been a significant increase in the regulations surrounding the safety of pharmaceutical products. Regardless of size or geolocation, all life science companies are obliged to collect, investigate and monitor adverse events related to their entire portfolio of medicinal products. Over the years, various legislation has defined the process of adverse event reporting, and most recently, E2B(R3) introduced the latest iteration to the ICH E2B technical specification.

The electronic transmission of adverse event information to stakeholders, using the International Conference on Harmonisation (ICH) “E2B” standard, is an essential component of global drug safety and pharmacovigilance operations. E2B(R3) is the latest iteration of these requirements with which the pharmaceutical industry and the designated organizations that assist with reporting safety information will be required to comply.

What is E2B(R3)?

Prior to the development and introduction of electronic submissions for adverse events, organizations shared safety information on hand-written forms. E2B introduced and defined the data elements that needed to be transmitted in individual case safety reports (ICSRs), regardless of the source or destination. The most recent set of changes, namely E2B(R3), is essentially the fourth major revision of E2B guidelines.

The FDA, EMA, and Japan’s Ministry of Health, Labour, and Welfare (MHLW) have all confirmed they will adopt E2B(R3) as their standard format for reporting of adverse events. All companies that currently report safety data to regulatory agencies or partners using E2B will move to the new E2B(R3) format over the coming years. The implantation of the new E2B(R3) standard in the EU is linked to other milestones in the implantation of the new EudraVigilance database at the EMA. Therefore a stepwise approach will be followed, and both standards E2B(R2) and E2B(R3) will be available for use during a transition period. According to the implementation plan, the EMA will send ICSRs in E2B(R3) format from Nov 2017 on. The pharmaceutical industry must be able to receive these messages but can still send ICSRs in the R2 format at least until IDMP is implemented.

Understanding Key Differences Between E2B (R2) and (R3)

It is crucial to understand the key differences between E2B (R2) and (R3) because the changes will have a significant impact on your safety systems. The majority of the changes are related to field modifications, with information moving from case to entry-level, and attachments and file formats for submissions also seeing changes.

One of the most important changes is that attachments can now be incorporated into the ICSR.xml file. Intended for the inclusion of literature articles, various file types are supported, such as PDF and JPEG.

Ultimately, the business objective of the E2B(R3) is to standardize the definition of the data elements used in the electronic transmission of different types of ICSRs, regardless of source and destination. On the other side, the technical objective is to
assist reporters and recipients (including pharmaceutical companies, regulatory authorities, and non-commercial
sponsors) in implementing systems to construct transmittable ICSR messages.

To learn about the challenges and opportunities introduced by the new E2B(R3) standard, as well as the likely impact on your drug safety business processes, download our whitepaper “Understanding the standards, challenges, and opportunities introduced by the new E2B R3 standard”, or contact our team of experts at info@extedo.com.


Dr. Andrea Striebel, Business Consultant, EXTEDO


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