FDA Adopts ICH Guideline on Transmission of Adverse Event Reports

| 24 February 2014 |  By 

US regulators have released the International Conference on Harmonisation's (ICH) E2B(R3) guideline on transmitting individual case safety reports (ICSRs) electronically, bringing the US into harmonization with the EU and Japan.

Background: ICH

ICH is a pharmaceutical harmonization group committed to bridging unnecessary regulatory gaps between the regulators of major economies. At present, its principal membership includes the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Japan's Ministry of Health, Labor and Welfare (MHLW). Other countries, including Canada and Australia, routinely adopt the group's guidelines as well.

ICH also includes three industry members: the European Federation of Pharmaceutical Industries Associations, the Japanese Pharmaceutical Manufacturers Association, and the Pharmaceutical Research and Manufacturers of America.

The aim of the group is to allow the regulatory processes of each to better align with those of the others, thereby allowing greater efficiencies for industry and regulators alike. This is perhaps best exemplified by the common technical document (CTD), which permits a company to submit a pharmaceutical dossier to all three countries with only minimal changes to a single module of the submission format to account for minor regional differences.

Background: ICSRs

In November 2012, ICH announced the adoption and release of changes to the safety reporting guideline E2B(R3) Clinical Safety Data Management: Data Elements for Transmission of ICSRs.

ICSRs are essentially adverse event reports, used to relay information to regulators about outcomes associated with the use of specific medical product(s).

"The ICSR can also be used for exchange of other information, such as medication error(s) that do not involve adverse events(s)/reaction(s)," ICH explained in its E2B(R3) guideline. "The information for the report is provided by a primary source, although, depending on regional requirements, new information, or for practical or logistical issues, a given ICSR can be updated or retransmitted by either the initial sender or a 3rd party."

The problem, ICH explained in its 2012 concept paper, was that its (R2) format was significantly different from its (R3) format, necessitating a new guideline on how to implement the latest format across regions and ensure version compatibility.

Final Guideline Released

The final guideline, E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide - Data Elements and Message Specification, "provides guidance on the data elements, terminology, and exchange standards for the submission of ICSRs to improve the inherent quality of adverse event data and enable improved handling and analysis of ICSRs," FDA said in a Federal Register notice announcing the document

In addition, "The E2B(R3) implementation guidance provides support for the implementation of software tools for creating, editing, sending, and receiving electronic ICSR messages," FDA wrote. It also contains instructions on how regulators and industry can use the ISO 27953-2 (Part 2) standard to exchange pharmacovigilance information among ICH regions.

The guideline has already been adopted in the EU and in Japan, and FDA's 21 February 2014 notice means the standard is now in effect in all ICH signatory regions.

FDA has also released ICH's Appendix to the Implementation Guide - Backwards and Forwards Compatibility, meant to "assist reporters and recipients in implementing systems with special focus on the recommendations for converting back and forth between E2B(R2) and E2B(R3) ICSR reports." The appendix includes schema files and other technical information, FDA said.


Guideline, Appendix and Schema

Federal Register Notice


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