§ 02 — Comparison

Compare regulatory pathways side-by-side

Benchmark MAHMAH, GMPGMP, HTAHTA and pathway requirements across up to three markets.

Country A

Country B

Country C

Highlight differences

Criterion	🇬🇧United Kingdom	🇺🇸United States
Authority & dossier
Regulatory authority	MHRA	FDA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	None
Reference agencies	FDA, EMA, Health Canada, Swissmedic +4	—
Lead pathway (timeline & fees) — International Recognition Procedure (IRP) · New Drug Application — 505(b)(1)
Pathway name	International Recognition Procedure (IRP)	New Drug Application — 505(b)(1)
Approval timeline	60–110 days	304–365 days
Application fee	GBP 35,305	USD 4,310,002
Annual renewal	GBP 0	USD 416,734
Local representative	Not required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Not required	Required
MAH & local presence
Local entity required	Yes	No
Local responsible person	Yes	Yes
RP role	Qualified Person (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.	US Agent: a person residing or maintaining a place of business in the US, designated to act on behalf of the foreign establishment for FDA communications, including notification of inspections.
Accelerated pathways
Designations available	4 designations	6 designations
Examples	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
Post-approval lifecycle
Variations framework	Variations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped variations across multiple authorisations.	FDA classifies post-approval changes as: Annual Reportable, Changes Being Effected (CBE-0 immediate, CBE-30 with 30-day pre-implementation notice), and Prior Approval Supplements (PAS) — the most significant changes requiring FDA approval before implementation. Major manufacturing or labelling changes typically require a PAS.
Renewal cycle	Initial 5-year renewal; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.	FDA does not require periodic renewal of NDAs or BLAs — approvals remain in effect indefinitely subject to compliance, payment of annual program fees, and post-marketing requirements. Annual reports are required.
Pharmacovigilance	MHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.	Mandatory expedited reporting of serious unexpected ADRs within 15 calendar days; periodic safety reports (PADERs/PAERs) for the first 3 years post-approval, then annually. PSURs in ICH E2C(R2) format accepted in lieu of PADERs by agreement. FAERS database receives spontaneous reports. Post-Marketing Requirements (PMRs) and Commitments (PMCs) tracked publicly.
Unlicensed access
Named Patient Supply	Available	Available
Compassionate Use	Available	Available
Emergency Import	Available	Available
Parallel Import	Permitted	Not permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	30–60 days	30–30 days
GCP standard	ICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)	ICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56
Pricing & reimbursement
Price regulation	Regulated	Free pricing
Reference pricing	No	No
HTA required	Yes	No
HTA body	NICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)	ICER (Institute for Clinical and Economic Review) — independent, non-binding

Verdict colours indicate lower, moderate, or higher regulatory burden — they're not value judgements on a market.

Authority & dossier

Regulatory authority

United KingdomMHRA
United StatesFDA

English submissions

United KingdomYes
United StatesYes

CTD accepted

United KingdomYes
United StatesYes

eCTD accepted

United KingdomYes
United StatesYes

Reliance pathway

United KingdomAvailable
United StatesNone

Reference agencies

United KingdomFDA, EMA, Health Canada, Swissmedic +4
United States—

Lead pathway (timeline & fees) — International Recognition Procedure (IRP) · New Drug Application — 505(b)(1)

Pathway name

United KingdomInternational Recognition Procedure (IRP)
United StatesNew Drug Application — 505(b)(1)

Approval timeline

United Kingdom60–110 days
United States304–365 days

Application fee

United KingdomGBP 35,305
United StatesUSD 4,310,002

Annual renewal

United KingdomGBP 0
United StatesUSD 416,734

Local representative

United KingdomNot required
United StatesNot required

Local manufacturing

United KingdomNot required
United StatesNot required

GMP inspection

United KingdomNot required
United StatesRequired

MAH & local presence

Local entity required

United KingdomYes
United StatesNo

Local responsible person

United KingdomYes
United StatesYes

RP role

United KingdomQualified Person (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.
United StatesUS Agent: a person residing or maintaining a place of business in the US, designated to act on behalf of the foreign establishment for FDA communications, including notification of inspections.

Accelerated pathways

Designations available

United Kingdom4 designations
United States6 designations

Examples

United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3

Post-approval lifecycle

Variations framework

United KingdomVariations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped variations across multiple authorisations.
United StatesFDA classifies post-approval changes as: Annual Reportable, Changes Being Effected (CBE-0 immediate, CBE-30 with 30-day pre-implementation notice), and Prior Approval Supplements (PAS) — the most significant changes requiring FDA approval before implementation. Major manufacturing or labelling changes typically require a PAS.

Renewal cycle

United KingdomInitial 5-year renewal; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.
United StatesFDA does not require periodic renewal of NDAs or BLAs — approvals remain in effect indefinitely subject to compliance, payment of annual program fees, and post-marketing requirements. Annual reports are required.

Pharmacovigilance

United KingdomMHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.
United StatesMandatory expedited reporting of serious unexpected ADRs within 15 calendar days; periodic safety reports (PADERs/PAERs) for the first 3 years post-approval, then annually. PSURs in ICH E2C(R2) format accepted in lieu of PADERs by agreement. FAERS database receives spontaneous reports. Post-Marketing Requirements (PMRs) and Commitments (PMCs) tracked publicly.

Unlicensed access

Named Patient Supply

United KingdomAvailable
United StatesAvailable

Compassionate Use

United KingdomAvailable
United StatesAvailable

Emergency Import

United KingdomAvailable
United StatesAvailable

Parallel Import

United KingdomPermitted
United StatesNot permitted

Clinical trials

CTA approval

United KingdomRequired
United StatesRequired

Ethics approval

United KingdomYes
United StatesYes

CTA timeline

United Kingdom30–60 days
United States30–30 days

GCP standard

United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)
United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56

Pricing & reimbursement

Price regulation

United KingdomRegulated
United StatesFree pricing

Reference pricing

United KingdomNo
United StatesNo

HTA required

United KingdomYes
United StatesNo

HTA body

United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding