The International Conference on Harmonisation (ICH), an international regulatory harmonization body comprised of agencies from the US, EU and Japan, has announced the endorsement of a working paper on the electronic transmission of individual case safety reports (ICSRs), reflecting ICH's sense that new revisions to other documents require "additional guidance and support activities."
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.
"Conceptually, an ICSR is a report of information describing adverse event(s) / reaction(s) experienced by an individual patient; the event(s)/reaction(s) can be related to the administration of one or more medicinal products at a particular point in time," ICH explained in the E2B(R3) guideline.
"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 added. "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."
New Guidance, New Problems
The problem, explains ICH in a new final concept paper endorsed by its Steering Committee, is that the E2B(R3) guideline is "complex and technically very different from the current E2B(R2) format."
"E2B(R3) implementation will require conceptual changes to business processes and due to differences in regional legislation, questions are expected regarding implementation across the ICH regions," it wrote. "Additionally, the use of constrained ISO IDMP [Identification of Medical Products] terminologies in ICSRs will require additional guidance and support activities."
As a result, ICH said it anticipated receiving a large volume of queries from stakeholders regarding the new format, and is now looking to head off many of those requests by establishing a new working group to "progress implementation activities and ensure transition from E2B(R2) to E2B(R3).
To that end, the E2B(R3) International Working Group (IWG) had prioritized the development and publication of several deliverables, including:
- establishment of an ICH mailbox to receive questions
- finalization of a Change Control Process for documents in the Implementation Guide (IG) package
- maintenance of technical documents related to E2B(R3)
- ensure implementation consistency across regions
- definition of E2B(R3) codes as needed
- create initial documentation for use of IDs/terms referenced in E2B(R3) IG.
The new working group's charge can be found here.
ICH Concept Paper