ICH E2D

E559691

ICH guideline pharmacovigilance guideline

ICH E2D is an International Council for Harmonisation guideline that provides standards for post-approval safety data management, including the collection, evaluation, and reporting of safety information for marketed medicinal products.

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Statements (48)

Predicate	Object
instanceOf	ICH guideline ⓘ pharmacovigilance guideline ⓘ
abbreviationOf	International Council for Harmonisation Guideline E2D NERFINISHED ⓘ
addresses	definitions related to post-approval safety data ⓘ expedited reporting time frames ⓘ follow-up of safety reports ⓘ literature case reporting ⓘ minimum information for a valid individual case safety report ⓘ reporting of safety information from compassionate use or named-patient programs ⓘ reporting of safety information from non-interventional studies ⓘ reporting of safety information from post-authorization studies ⓘ reporting of safety information from registries ⓘ reporting of safety information from special situations such as pregnancy and overdose ⓘ unlisted and serious adverse reactions ⓘ
appliesTo	clinical trial safety reports after marketing authorisation ⓘ marketed medicinal products ⓘ post-marketing individual case safety reports ⓘ spontaneous reports of adverse drug reactions ⓘ
covers	company and regulatory responsibilities for safety data management ⓘ data quality and completeness in safety reports ⓘ electronic and paper-based safety reporting ⓘ handling of duplicate reports ⓘ
defines	criteria for expedited reporting of individual case safety reports ⓘ standards for collection of post-marketing safety data ⓘ standards for evaluation of post-marketing safety data ⓘ standards for reporting of post-marketing safety data ⓘ
domain	drug safety regulation ⓘ pharmacovigilance ⓘ
focusesOn	expedited reporting of safety information ⓘ post-approval safety data management ⓘ safety information for marketed medicinal products ⓘ
fullName	ICH Harmonised Tripartite Guideline E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting NERFINISHED ⓘ
issuedBy	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use NERFINISHED ⓘ
objective	to harmonise international standards for post-approval safety reporting ⓘ to improve consistency of expedited safety reporting across regions ⓘ to support protection of public health through timely safety communication ⓘ
regulatoryRegion	European Union NERFINISHED ⓘ ICH regions ⓘ Japan NERFINISHED ⓘ United States NERFINISHED ⓘ
relatedTo	ICH E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting NERFINISHED ⓘ ICH E2B Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports NERFINISHED ⓘ ICH E2C Periodic Benefit-Risk Evaluation Report (PBRER) NERFINISHED ⓘ ICH E2E Pharmacovigilance Planning NERFINISHED ⓘ
status	harmonised guideline ⓘ
usedBy	marketing authorisation holders ⓘ pharmaceutical companies ⓘ regulatory authorities ⓘ

Referenced by (1)

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ICH E2A Clinical Safety Data Management → relatedTo → ICH E2D ⓘ