ICH E2C
E555158
ICH E2C is an International Council for Harmonisation guideline that defines standards for the periodic safety update reporting of medicinal products to support ongoing pharmacovigilance and risk management.
Observed surface forms (1)
| Surface form | Occurrences |
|---|---|
| ICH E2C(R2) | 0 |
Statements (41)
| Predicate | Object |
|---|---|
| instanceOf |
ICH guideline
ⓘ
drug safety guideline ⓘ pharmacovigilance guideline ⓘ |
| abbreviationOf | International Council for Harmonisation guideline E2C NERFINISHED ⓘ |
| aimsTo |
facilitate global pharmacovigilance
ⓘ
harmonise international requirements for periodic safety update reports ⓘ integrate benefit-risk evaluation into periodic safety reporting ⓘ |
| appliesTo |
human medicinal products
ⓘ
marketed medicinal products ⓘ |
| defines |
content requirements for periodic safety update reports
ⓘ
format for periodic safety update reports ⓘ timing of periodic safety update reports ⓘ |
| focusesOn |
clinical safety data management for marketed drugs
ⓘ
periodic benefit-risk evaluation reports ⓘ periodic safety update reporting of medicinal products ⓘ |
| fullName |
Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
NERFINISHED
ⓘ
Periodic Benefit-Risk Evaluation Report (PBRER) NERFINISHED ⓘ |
| hasRevision |
ICH E2C(R1)
ⓘ
ICH E2C(R2) ⓘ |
| issuedBy | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use NERFINISHED ⓘ |
| objective |
improve consistency of safety reporting across regions
ⓘ
provide a common standard for periodic safety update reports ⓘ |
| partOf | ICH E2 clinical safety guidelines series NERFINISHED ⓘ |
| regulatoryScope |
European Union
NERFINISHED
ⓘ
ICH regions NERFINISHED ⓘ Japan NERFINISHED ⓘ United States NERFINISHED ⓘ |
| relatedTo |
ICH E2A
ⓘ
ICH E2B ⓘ ICH E2D ⓘ ICH E2E ⓘ drug safety reporting ⓘ pharmacovigilance ⓘ regulatory submissions for safety ⓘ |
| revises | ICH E2C NERFINISHED ⓘ |
| supersededBy | ICH E2C(R2) NERFINISHED ⓘ |
| supports |
ongoing pharmacovigilance
ⓘ
risk management of medicinal products ⓘ |
| usedBy |
marketing authorisation holders
ⓘ
pharmaceutical companies ⓘ regulatory authorities ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.