EMA VS FDA APPROVALS OF INNOVATIVE MEDICINES: A SYSTEMATIC ANALYSIS OF APPROVAL EXCLUSIVITY, APPROVAL SEQUENCING, REGULATORY TIMELINES (2021-2026)
Author(s)
Camille SEGUIER, PharmD1, Tea MOYA, PharmD1, Mathis Guffroy, PharmD candidate1, Elsa Duteil, MSc1, Clément Le Dissez, PharmD1, Daniel Moreira, MSc2, David Reyes, MSc2, Felix Steinbrenner, MSc2.
1PASS, Paris, France, 2Cellbyte, Munich, Germany.
1PASS, Paris, France, 2Cellbyte, Munich, Germany.
OBJECTIVES: To compare approval exclusivity, approval sequencing, agency timelines and indication scope between the FDA and EMA for innovative medicines authorized between 2021 and 2026.
METHODS: Data were extracted from the Cellbyte® database at the indication level. Innovative medicines, excluding generics and biosimilars, with at least one FDA or EMA approval between April 2021 and April 2026 were included. Approval exclusivity was assessed across all identified indications, while comparative analyses were restricted to indications approved by both agencies. Approval sequencing and inter-agency timelines were evaluated among dual-approved indications. Indication scope was classified as EMA-restrictive, FDA-restrictive, or equivalent.
RESULTS: Among 1,035 identified indications, 29% (n=300/1,035) received approval from both agencies, while 71% (n=735/1,035) remained exclusive to a single agency. FDA-exclusive indications represented 64% (n=472/735) versus 36% (n=263/735) for EMA-exclusive indications. Among dual-approved indications, the FDA provided the first regulatory approval in 61% (n=182/300) of cases. EMA indication scope was more restrictive than FDA indication scope in 59% (n=177/300) of matched indications, compared with 24% (n=73/300) FDA-restrictive and 17% (n=50/300) equivalent indications. This pattern remained stable between 2021 and 2024. Thirty-two dual-approved indications with a first approval in Japan or China were excluded from timeline analyses. Inter-agency timelines showed marked asymmetry. When the FDA approved first (n=166/268), the median delay to EMA approval was 221 days (mean: 286). When the EMA approved first (n=102/268), the median delay to FDA approval was 309 days (mean: 618).
CONCLUSIONS: Regulatory divergence between the FDA and EMA was observed across approval exclusivity, sequencing of regulatory approvals, inter-agency approval timelines, and indication scope. The FDA more frequently granted the first regulatory approval and was associated with a greater number of exclusive indications. Subsequent EMA approvals following FDA authorization occurred more rapidly than subsequent FDA approvals following EMA authorization. EMA indication scope was more frequently restrictive than FDA indication scope.
METHODS: Data were extracted from the Cellbyte® database at the indication level. Innovative medicines, excluding generics and biosimilars, with at least one FDA or EMA approval between April 2021 and April 2026 were included. Approval exclusivity was assessed across all identified indications, while comparative analyses were restricted to indications approved by both agencies. Approval sequencing and inter-agency timelines were evaluated among dual-approved indications. Indication scope was classified as EMA-restrictive, FDA-restrictive, or equivalent.
RESULTS: Among 1,035 identified indications, 29% (n=300/1,035) received approval from both agencies, while 71% (n=735/1,035) remained exclusive to a single agency. FDA-exclusive indications represented 64% (n=472/735) versus 36% (n=263/735) for EMA-exclusive indications. Among dual-approved indications, the FDA provided the first regulatory approval in 61% (n=182/300) of cases. EMA indication scope was more restrictive than FDA indication scope in 59% (n=177/300) of matched indications, compared with 24% (n=73/300) FDA-restrictive and 17% (n=50/300) equivalent indications. This pattern remained stable between 2021 and 2024. Thirty-two dual-approved indications with a first approval in Japan or China were excluded from timeline analyses. Inter-agency timelines showed marked asymmetry. When the FDA approved first (n=166/268), the median delay to EMA approval was 221 days (mean: 286). When the EMA approved first (n=102/268), the median delay to FDA approval was 309 days (mean: 618).
CONCLUSIONS: Regulatory divergence between the FDA and EMA was observed across approval exclusivity, sequencing of regulatory approvals, inter-agency approval timelines, and indication scope. The FDA more frequently granted the first regulatory approval and was associated with a greater number of exclusive indications. Subsequent EMA approvals following FDA authorization occurred more rapidly than subsequent FDA approvals following EMA authorization. EMA indication scope was more frequently restrictive than FDA indication scope.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR199
Topic
Epidemiology & Public Health, Health Policy & Regulatory
Topic Subcategory
Approval & Labeling, Health Disparities & Equity, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas