ICH E2A vs ICH E2D
Safety reporting before approval vs after — clinical trials vs post-marketing.
What a comparison is not
A comparison is SPEQ’s reading of how two published documents differ. Neither is the right answer, it is not a determination of which applies to you, and neither is summarised in a way that replaces reading it.
ICH E2A defines standards for expedited safety reporting during clinical development — including definitions and the handling of serious, unexpected adverse reactions in trials. ICH E2D covers post-approval safety data management — the definitions and standards for expedited reporting once a product is marketed. They cover the same discipline (pharmacovigilance) at two different lifecycle stages.
| ASPECT | ICH E2A | ICH E2D |
|---|---|---|
| Stage | Clinical development (pre-approval) | Post-approval (marketed product) |
| Focus | Expedited reporting of SUSARs in trials; key definitions | Post-marketing expedited reporting standards and definitions |
| Source of reports | Clinical trials | Spontaneous reports, literature, post-marketing sources |
| Key concept | Serious, unexpected, related (SUSAR) | Post-approval ICSR handling and expedited criteria |
| Companion guidance | E2B (ICSR format), E2F (DSUR) | E2B (ICSR), E2C (PBRER), signal management |
Apply ICH E2A during clinical development — it frames the definitions and expedited reporting of serious, unexpected adverse reactions arising in trials.
Apply ICH E2D once a product is marketed — it covers post-approval safety data management and the expedited-reporting standards for individual case safety reports from the marketed setting.
Same discipline, two lifecycle stages: E2A governs safety reporting in the trial setting; E2D governs it after approval. A product moving from development to market transitions from E2A-driven trial reporting to E2D-driven post-marketing reporting, with E2B providing the common ICSR format throughout and E2C/PBRER handling periodic post-marketing summaries.
ICH E2A vs ICH E2D: frequently asked questions
Common questions on how ICH E2A and ICH E2D differ and when each applies.
What is the difference between ICH E2A and E2D?
E2A addresses clinical-trial (pre-approval) safety data management and expedited reporting of serious, unexpected adverse reactions; E2D addresses post-approval (marketed-product) safety data management and expedited reporting. They cover pharmacovigilance at different lifecycle stages.
What is a SUSAR?
A Suspected Unexpected Serious Adverse Reaction — a serious adverse reaction in a clinical trial that is both unexpected (not consistent with the reference safety information) and suspected to be related to the investigational product. E2A frames how such events are identified and expedited.
How do these relate to E2B and E2C?
E2B defines the electronic format for individual case safety reports (ICSRs) used in both settings; E2C defines the Periodic Benefit-Risk Evaluation Report (PBRER) for post-marketing periodic reporting. E2A/E2D set the reporting standards; E2B/E2C provide the format and periodic-summary structures.