New Challenges in Pharmacovigilance

The E2B(R2) standard was first adapted in February 2001. Since then, many changes have been made across the countries where it applies. These changes have promoted an update to E2B(R2) with the new E2B(R3) - which will have a major impact on pharmacovigilance systems and processes, particularly on adverse event reporting and collection of data on drugs. Based on IQVIA’s extensive experience in this area, this insight brief examines how the new standards impact day-to-day safety operations and offers tips for project management of the implementation of the new standards.

These latest standards will have a major impact on pharmacovigilance systems and processes, particularly on adverse event reporting and collection of data on drugs. Biopharma companies will be required to overhaul individual case safety report (ICSR) processes and procedures to prepare for the rapidly approaching deadline for implementing these new standards. Key changes from the current E2B(R2) standards include an increased number of data elements (333 for E2B(R3) vs. 271 for E2B(R2)) and a higher number of individual elements in an average file (with 38 new elements and changes to 33 existing elements in E2B(R3)).

Under the European Medicines Agency (EMA) plan, the E2B(R3) standard will come into effect in November 2017. In the EU, the new standard will apply to both interventional study reports and spontaneous reports. The U.S. Food and Drug Administration (FDA) “Regional Implementation Specifications for ICH E2B(R3) Implementation” were published on June 22, 2016. There is currently no firm deadline for mandatory E2B(R3) implementation in the U.S., but this is expected in 2017 or 2018. Under the Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) plan, the new ICH E2B(R3) standard has been optional since April 1, 2016, and will be mandatory as of April 1, 2019.

Although regional variations will apply, the implementation of E2B(R3) will not conflict across regions. Furthermore, additional regional data elements will not hamper the exchange of data across regions. Based on IQVIA’s extensive experience in this area, this insight brief examines how the new standards impact day-to-day safety operations and offers tips for project management of the implementation of the new standards. Impacts on systems and business processes are discussed, and a plan is outlined to support compliance once the standards come into force. Guidelines for project management – including timeframes, training requirements and sources of advice – aim to ensure seamless implementation of ICH E2B(R3).

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