On April 7th, 2022, the US FDA announced that they had adopted the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E8(R1) Harmonised Guideline on General Considerations for Clinical Studies. The ICH E8(R1) reached Step 4 (recommendation to be adopted by ICH Regulatory Bodies) in early October 2021.
The original ICH Harmonised Guideline superficially refers to "ICH E2-E2F Pharmacovigilance, and, for interventional clinical trials, in particular, ICH E6" (this means R2 is not excluded):
“6.2.1 Safety Monitoring
The goals of safety monitoring are to protect study participants and to characterize the safety profile of the drug. Procedures and systems for identifying, monitoring, and reporting safety concerns during the study should be specified. The approach should reflect the ICH E8(R1) Guideline 19 type and objectives of the study, the risks to the study participants, and what is known about the drug and the study population. Guidance is available on reporting safety data to appropriate authorities and on the content and timing of safety reports (ICH E2-E2F Pharmacovigilance, and, for interventional clinical trials, in particular, ICH E6).”
In contrast to the original ICH Guideline, the presently FDA-adopted text of the Guideline explicitly quotes the E2B(R3) standards.
The adapted Guideline refers, among others, to the following ICH Efficacy Guidelines for industry and for interventional clinical trials in particular:
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E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide — Data Elements and Message Specification (February 2014)
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E2B(R3) Appendix I (B) to the ICH E2B(R3) ICSRs Implementation Guide — Backwards and Forwards Compatibility (February 2014)
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E2B(R3) FDA Regional Implementation Specifications for ICH E2B(R3) Implementation — Postmarket Submission of Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines — Technical Specifications Document (June 2016)
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