Impact Analysis
The impact analysis tool calculates the downstream regulatory impact of product changes. Select a change to see all affected markets, dossier modules, labeling artefacts, and required variation filings. Impact scores are calculated based on the number of affected markets, module depth, and variation classification.
CHG-2024-0001 Analytical Method Change
Kcluximab — Specification Change for Kcluximab — minor update…
55
Impact Score
Impacted Markets (2)
CNES
Impacted Modules (2)
4.2.13.2.P.3
Variations (1)
MinorOverdue
CHG-2023-0002 Container Closure Change
Verasenib — Labeling Change for Verasenib — routine update…
85
Impact Score
Impacted Markets (2)
JPTW
Impacted Modules (3)
3.2.P.32.3.P4.2.1
Variations (4)
MajorApproved
MinorCompleted
Type IAIn Progress
Type IBActive
CHG-2022-0003 Specification Change
Cardilostat — Analytical Method Change for Cardilostat — routine update…
115
Impact Score
Impacted Markets (8)
CNBRCHDEIN+3
Impacted Modules (1)
2.3.P
Variations (4)
Type IBApproved
Type IAOverdue
Type IIOverdue
Type IBCompleted
CHG-2021-0004 Shelf Life Extension
Neprilozone — Formulation Change for Neprilozone — major revision…
90
Impact Score
Impacted Markets (3)
USSEDK
Impacted Modules (3)
2.3.P3.2.S3.2.P.3
Variations (3)
Type IBDraft
Type IAActive
MinorApproved
CHG-2024-0005 Shelf Life Extension
Immunovant-α — Container Closure Change for Immunovant-α — routine update…
110
Impact Score
Impacted Markets (7)
CHDETWINMX+2
Impacted Modules (1)
3.2.P.3
Variations (4)
MinorFailed
Type IISubmitted
MinorPending
MajorFailed
CHG-2023-0006 Specification Change
Dupitumacon — New Dosage Strength for Dupitumacon — major revision…
165
Impact Score
Impacted Markets (8)
USEUCAGBES+3
Impacted Modules (4)
5.3.53.2.P.34.2.13.2.P
Variations (4)
Type IABlocked
Type IAActive
MinorSubmitted
Type IIFailed
CHG-2022-0007 Facility Change
Neuravastatin — Specification Change for Neuravastatin — major revision…
135
Impact Score
Impacted Markets (7)
CNGBITESKR+2
Impacted Modules (3)
2.3.P3.2.S4.2.1
Variations (4)
MajorCompleted
Type IIDraft
MajorIn Progress
MinorOverdue
CHG-2021-0008 Storage Condition Change
Alzabistat — New Dosage Strength for Alzabistat — major revision…
90
Impact Score
Impacted Markets (2)
NLRU
Impacted Modules (4)
3.2.P.33.2.S5.3.52.3.P
Variations (2)
Type IAIn Progress
MajorFailed
CHG-2024-0009 Specification Change
Raredimab — New Dosage Strength for Raredimab — minor update…
40
Impact Score
Impacted Markets (2)
DETW
Impacted Modules (1)
3.2.P
Variations (1)
Type IBOverdue
CHG-2023-0010 Facility Change
Fabrizyme-β — Formulation Change for Fabrizyme-β — critical change…
80
Impact Score
Impacted Markets (3)
CNBRSA
Impacted Modules (2)
2.3.P3.2.S
Variations (4)
Type IBBlocked
MinorSubmitted
MinorBlocked
MajorFailed