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ICH guideline

ICH E2B(R3) EWG/IWG: Electronic Transmission of Individual Case Safety Reports (ICSRs)

ICH guideline · Efficacy Guidelines

Key facts

ICH code E2B(R3) EWG/IWG
Title Electronic Transmission of Individual Case Safety Reports (ICSRs)
Guideline series Efficacy Guidelines
ICH summary (excerpt) In July 2013, the ICH Steering Committee endorsed the establishment of the IWG on E2B(R3) to progress implementation activities and ensure transition from E2B(R2) to E2B(R3). The E2B(R3) Implementation Package, Q&As and further information is available on the ESTRI page.
File E2B(R3) Training Material - Module III
File type PDF
File on ich.org database.ich.org

At a glance

  • Yes Full text searchable in Orca1
  • E2B(R3) Training Material - Module III Files published by ICH
  • None FDA guidance documents based on this guideline

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ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.

Source: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Guideline summaries are ICH material, reproduced with acknowledgement

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