§ 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 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) — New Drug Application — 505(b)(1) · Centralised Procedure · International Recognition Procedure (IRP)
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
MAH & local presence
Local entity required	No	Yes	Yes
Local responsible person	Yes	Yes	Yes
RP role	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.	Qualified Person Responsible for Pharmacovigilance (QPPV) — must reside and operate in the EU/EEA — is responsible for the establishment and maintenance of the pharmacovigilance system. A Qualified Person (QP) in the EU/EEA performs batch certification under Article 51 of Directive 2001/83/EC. Local Contact Person for pharmacovigilance required in each Member State where the product is marketed (since 2012 GVP).	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.
Accelerated pathways
Designations available	6 designations	6 designations	4 designations
Examples	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3	Accelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	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.	Commission Regulation (EC) 1234/2008 establishes four categories: Type IA (minor — Do and Tell, 12-month notification), Type IAIN (minor — immediate notification), Type IB (minor — Tell, Wait, and Do, 30-day default), Type II (major — prior approval, 60–90 days), and Extensions (Annex I changes — full review). Worksharing procedures consolidate variations across multiple authorisations.	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.
Renewal cycle	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.	Initial 5-year renewal — application 9 months before expiry. After the first renewal, MA is granted for unlimited duration unless the CHMP/NCA, on justified grounds relating to pharmacovigilance, decides on one additional 5-year renewal.	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.
Pharmacovigilance	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.	Comprehensive PV framework under Directive 2010/84/EU and Regulation (EU) 1235/2010, codified in Good Pharmacovigilance Practices (GVP). Pharmacovigilance System Master File (PSMF) required. Periodic Safety Update Reports (PSURs) on EU-harmonised birth-date list. Risk Management Plans for all new MAs and significant variations. Suspected serious ADR reporting to EudraVigilance within 15 days. Black triangle (▼) for additional monitoring of selected products.	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.
Unlicensed access
Named Patient Supply	Available	Available	Available
Compassionate Use	Available	Available	Available
Emergency Import	Available	Available	Available
Parallel Import	Not permitted	Permitted	Permitted
Clinical trials
CTA approval	Required	Required	Required
Ethics approval	Yes	Yes	Yes
CTA timeline	30–30 days	60–106 days	30–60 days
GCP standard	ICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56	ICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025	ICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)
Pricing & reimbursement
Price regulation	Free pricing	Regulated	Regulated
Reference pricing	No	Yes	No
HTA required	No	Yes	Yes
HTA body	ICER (Institute for Clinical and Economic Review) — independent, non-binding	EU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)	NICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)

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

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) — New Drug Application — 505(b)(1) · Centralised Procedure · International Recognition Procedure (IRP)

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

MAH & local presence

Local entity required

United StatesNo
European UnionYes
United KingdomYes

Local responsible person

United StatesYes
European UnionYes
United KingdomYes

RP role

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.
European UnionQualified Person Responsible for Pharmacovigilance (QPPV) — must reside and operate in the EU/EEA — is responsible for the establishment and maintenance of the pharmacovigilance system. A Qualified Person (QP) in the EU/EEA performs batch certification under Article 51 of Directive 2001/83/EC. Local Contact Person for pharmacovigilance required in each Member State where the product is marketed (since 2012 GVP).
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.

Accelerated pathways

Designations available

United States6 designations
European Union6 designations
United Kingdom4 designations

Examples

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

Post-approval lifecycle

Variations framework

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.
European UnionCommission Regulation (EC) 1234/2008 establishes four categories: Type IA (minor — Do and Tell, 12-month notification), Type IAIN (minor — immediate notification), Type IB (minor — Tell, Wait, and Do, 30-day default), Type II (major — prior approval, 60–90 days), and Extensions (Annex I changes — full review). Worksharing procedures consolidate variations across multiple authorisations.
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.

Renewal cycle

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.
European UnionInitial 5-year renewal — application 9 months before expiry. After the first renewal, MA is granted for unlimited duration unless the CHMP/NCA, on justified grounds relating to pharmacovigilance, decides on one additional 5-year renewal.
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.

Pharmacovigilance

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.
European UnionComprehensive PV framework under Directive 2010/84/EU and Regulation (EU) 1235/2010, codified in Good Pharmacovigilance Practices (GVP). Pharmacovigilance System Master File (PSMF) required. Periodic Safety Update Reports (PSURs) on EU-harmonised birth-date list. Risk Management Plans for all new MAs and significant variations. Suspected serious ADR reporting to EudraVigilance within 15 days. Black triangle (▼) for additional monitoring of selected products.
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.

Unlicensed access

Named Patient Supply

United StatesAvailable
European UnionAvailable
United KingdomAvailable

Compassionate Use

United StatesAvailable
European UnionAvailable
United KingdomAvailable

Emergency Import

United StatesAvailable
European UnionAvailable
United KingdomAvailable

Parallel Import

United StatesNot permitted
European UnionPermitted
United KingdomPermitted

Clinical trials

CTA approval

United StatesRequired
European UnionRequired
United KingdomRequired

Ethics approval

United StatesYes
European UnionYes
United KingdomYes

CTA timeline

United States30–30 days
European Union60–106 days
United Kingdom30–60 days

GCP standard

United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56
European UnionICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

United StatesFree pricing
European UnionRegulated
United KingdomRegulated

Reference pricing

United StatesNo
European UnionYes
United KingdomNo

HTA required

United StatesNo
European UnionYes
United KingdomYes

HTA body

United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding
European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)