§ 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	🇯🇵Japan
Authority & dossier
Regulatory authority	MHRA	PMDA
English submissions	Yes	No
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) · J-NDA (New Drug Application)
Pathway name	International Recognition Procedure (IRP)	J-NDA (New Drug Application)
Approval timeline	60–110 days	270–365 days
Application fee	GBP 35,305	JPY 38,950,800
Annual renewal	GBP 0	JPY 0
Local representative	Not required	Required
Local manufacturing	Not required	Not required
GMP inspection	Not required	Required
MAH & local presence
Local entity required	Yes	Yes
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.	Three named Japanese-based responsible persons required: General Marketing Compliance Officer (GVP), Marketing Authorisation Holder Quality Assurance Officer, and Safety Management Officer. All must reside in Japan. Foreign manufacturers must hold a Foreign Manufacturer Accreditation (FMA) for each manufacturing site.
Accelerated pathways
Designations available	4 designations	4 designations
Examples	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1	Priority Review, Orphan Drug Designation, Conditional Early Approval (Article 14-2-3) +1
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.	Three categories: Minor Change Notification (post-implementation notification, certain low-risk CMC and labelling), Partial Change Application (PCA — prior approval, mid-tier changes, ~6 months), and full Re-Application (major changes effectively requiring new NDA).
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.	Re-examination period of 4–10 years post-approval (8 years for new active substances, 10 years for orphan drugs and paediatric indications) — during which the applicant collects and submits post-marketing safety and efficacy data. Re-evaluation may follow at MHLW direction.
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.	MHLW operates the Drug Safety Information Reporting System; expedited reporting of serious unexpected ADRs within 15 days. PSURs aligned with global birth dates. J-RMP required for all new approvals. The Medical Information Database Network (MID-NET) provides real-world data infrastructure for active surveillance.
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)	J-GCP (Ministerial Ordinance No. 28, 1997, as amended) — fully ICH E6 aligned
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	No	Yes
HTA required	Yes	Yes
HTA body	NICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)	Chuikyo (Central Social Insurance Medical Council) and C2H (Center for Outcomes Research and Economic Evaluation for Health, NIPH)

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

Authority & dossier

Regulatory authority

United KingdomMHRA
JapanPMDA

English submissions

United KingdomYes
JapanNo

CTD accepted

United KingdomYes
JapanYes

eCTD accepted

United KingdomYes
JapanYes

Reliance pathway

United KingdomAvailable
JapanNone

Reference agencies

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

Lead pathway (timeline & fees) — International Recognition Procedure (IRP) · J-NDA (New Drug Application)

Pathway name

United KingdomInternational Recognition Procedure (IRP)
JapanJ-NDA (New Drug Application)

Approval timeline

United Kingdom60–110 days
Japan270–365 days

Application fee

United KingdomGBP 35,305
JapanJPY 38,950,800

Annual renewal

United KingdomGBP 0
JapanJPY 0

Local representative

United KingdomNot required
JapanRequired

Local manufacturing

United KingdomNot required
JapanNot required

GMP inspection

United KingdomNot required
JapanRequired

MAH & local presence

Local entity required

United KingdomYes
JapanYes

Local responsible person

United KingdomYes
JapanYes

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.
JapanThree named Japanese-based responsible persons required: General Marketing Compliance Officer (GVP), Marketing Authorisation Holder Quality Assurance Officer, and Safety Management Officer. All must reside in Japan. Foreign manufacturers must hold a Foreign Manufacturer Accreditation (FMA) for each manufacturing site.

Accelerated pathways

Designations available

United Kingdom4 designations
Japan4 designations

Examples

United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
JapanPriority Review, Orphan Drug Designation, Conditional Early Approval (Article 14-2-3) +1

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.
JapanThree categories: Minor Change Notification (post-implementation notification, certain low-risk CMC and labelling), Partial Change Application (PCA — prior approval, mid-tier changes, ~6 months), and full Re-Application (major changes effectively requiring new NDA).

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.
JapanRe-examination period of 4–10 years post-approval (8 years for new active substances, 10 years for orphan drugs and paediatric indications) — during which the applicant collects and submits post-marketing safety and efficacy data. Re-evaluation may follow at MHLW direction.

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.
JapanMHLW operates the Drug Safety Information Reporting System; expedited reporting of serious unexpected ADRs within 15 days. PSURs aligned with global birth dates. J-RMP required for all new approvals. The Medical Information Database Network (MID-NET) provides real-world data infrastructure for active surveillance.

Unlicensed access

Named Patient Supply

United KingdomAvailable
JapanAvailable

Compassionate Use

United KingdomAvailable
JapanAvailable

Emergency Import

United KingdomAvailable
JapanAvailable

Parallel Import

United KingdomPermitted
JapanNot permitted

Clinical trials

CTA approval

United KingdomRequired
JapanRequired

Ethics approval

United KingdomYes
JapanYes

CTA timeline

United Kingdom30–60 days
Japan30–30 days

GCP standard

United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)
JapanJ-GCP (Ministerial Ordinance No. 28, 1997, as amended) — fully ICH E6 aligned

Pricing & reimbursement

Price regulation

United KingdomRegulated
JapanRegulated

Reference pricing

United KingdomNo
JapanYes

HTA required

United KingdomYes
JapanYes

HTA body

United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)
JapanChuikyo (Central Social Insurance Medical Council) and C2H (Center for Outcomes Research and Economic Evaluation for Health, NIPH)