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Life Sciences

What Is E2B(R3)?


E2B(R3) doesn’t have a direct translation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) published guidelines that have designated “E” to stand for efficacy. The work carried out by ICH under the efficacy heading relates to the design, conduct, safety, and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes, and the use of pharmacogenetics and genomics techniques to produce better targeted medicines. All “E2” guidelines relate to pharmacovigilance. The official E2B(R3) document is titled “Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports.”

There was a time when people shared safety information on a hand-written forms. Then, E2B was introduced. E2B essentially defines what data elements need to be transmitted in individual case safety reports (ICSRs), regardless of the source or destination. E2B(R3) is actually 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 submission format. All companies that currently report safety data to regulatory agencies or partners using E2B will be required to adopt the new E2B(R3) format.

To learn about E2B(R3), the impact it is likely to have on drug safety business processes, and some ideas for how to move forward, fill out the form below or click here.

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Indy Ahluwalia

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