Comparison Tool

Compare regulatory pathways side-by-side

Pick 2 or 3 countries to benchmark timelines, fees, requirements and supply pathways across MAHMAH, GMPGMP, HTAHTA and more.

Country A

Country B

Country C (optional)

Criterion	🇺🇸United States	🇪🇺European Union	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	FDA	EMA	MHRA
English submissions	Yes	Yes	Yes
CTD accepted	Yes	Yes	Yes
eCTD accepted	Yes	Yes	Yes
Reliance pathway	None	Available	Available
Reference agencies	—	—	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees)
Pathway name	New Drug Application — 505(b)(1)	Centralised Procedure	International Recognition Procedure (IRP)
Approval timeline	304–365 days	210–277 days	60–110 days
Application fee	USD 4,310,002	EUR 358,800	GBP 35,305
Annual renewal	USD 416,734	EUR 122,500	GBP 0
Local representative	Not required	Required	Not required
Local manufacturing	Not required	Not required	Not required
GMP inspection	Required	Required	Not required

Authority & dossier

Regulatory authority

🇺🇸United StatesFDA
🇪🇺European UnionEMA
🇬🇧United KingdomMHRA

English submissions

🇺🇸United StatesYes
🇪🇺European UnionYes
🇬🇧United KingdomYes

CTD accepted

🇺🇸United StatesYes
🇪🇺European UnionYes
🇬🇧United KingdomYes

eCTD accepted

🇺🇸United StatesYes
🇪🇺European UnionYes
🇬🇧United KingdomYes

Reliance pathway

🇺🇸United StatesNone
🇪🇺European UnionAvailable
🇬🇧United KingdomAvailable

Reference agencies

🇺🇸United States—
🇪🇺European Union—
🇬🇧United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees)

Pathway name

🇺🇸United StatesNew Drug Application — 505(b)(1)
🇪🇺European UnionCentralised Procedure
🇬🇧United KingdomInternational Recognition Procedure (IRP)

Approval timeline

🇺🇸United States304–365 days
🇪🇺European Union210–277 days
🇬🇧United Kingdom60–110 days

Application fee

🇺🇸United StatesUSD 4,310,002
🇪🇺European UnionEUR 358,800
🇬🇧United KingdomGBP 35,305

Annual renewal

🇺🇸United StatesUSD 416,734
🇪🇺European UnionEUR 122,500
🇬🇧United KingdomGBP 0

Local representative

🇺🇸United StatesNot required
🇪🇺European UnionRequired
🇬🇧United KingdomNot required

Local manufacturing

🇺🇸United StatesNot required
🇪🇺European UnionNot required
🇬🇧United KingdomNot required

GMP inspection

🇺🇸United StatesRequired
🇪🇺European UnionRequired
🇬🇧United KingdomNot required

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