§ 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	🇯🇵Japan	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	PMDA	MHRA
English submissions	No	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	None	Available
Reference agencies	—	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — J-NDA (New Drug Application) · International Recognition Procedure (IRP)
Pathway name	J-NDA (New Drug Application)	International Recognition Procedure (IRP)
Approval timeline	270–365 days	60–110 days
Application fee	JPY 38,950,800	GBP 35,305
Annual renewal	JPY 0	GBP 0
Local representative	Required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Not required
MAH & local presence
Local entity required	Yes	Yes
Local responsible person	Yes	Yes
RP role	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.	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	4 designations	4 designations
Examples	Priority Review, Orphan Drug Designation, Conditional Early Approval (Article 14-2-3) +1	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	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).	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	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.	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	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.	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
Compassionate Use	Available	Available
Emergency Import	Available	Available
Parallel Import	Not permitted	Permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	30–30 days	30–60 days
GCP standard	J-GCP (Ministerial Ordinance No. 28, 1997, as amended) — fully ICH E6 aligned	ICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	Yes	No
HTA required	Yes	Yes
HTA body	Chuikyo (Central Social Insurance Medical Council) and C2H (Center for Outcomes Research and Economic Evaluation for Health, NIPH)	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

JapanPMDA
United KingdomMHRA

English submissions

JapanNo
United KingdomYes

CTD accepted

JapanYes
United KingdomYes

eCTD accepted

JapanYes
United KingdomYes

Reliance pathway

JapanNone
United KingdomAvailable

Reference agencies

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

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

Pathway name

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

Approval timeline

Japan270–365 days
United Kingdom60–110 days

Application fee

JapanJPY 38,950,800
United KingdomGBP 35,305

Annual renewal

JapanJPY 0
United KingdomGBP 0

Local representative

JapanRequired
United KingdomNot required

Local manufacturing

JapanNot required
United KingdomNot required

GMP inspection

JapanRequired
United KingdomNot required

MAH & local presence

Local entity required

JapanYes
United KingdomYes

Local responsible person

JapanYes
United KingdomYes

RP role

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.
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

Japan4 designations
United Kingdom4 designations

Examples

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

Post-approval lifecycle

Variations framework

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).
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

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.
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

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.
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

JapanAvailable
United KingdomAvailable

Compassionate Use

JapanAvailable
United KingdomAvailable

Emergency Import

JapanAvailable
United KingdomAvailable

Parallel Import

JapanNot permitted
United KingdomPermitted

Clinical trials

CTA approval

JapanRequired
United KingdomRequired

Ethics approval

JapanYes
United KingdomYes

CTA timeline

Japan30–30 days
United Kingdom30–60 days

GCP standard

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

Pricing & reimbursement

Price regulation

JapanRegulated
United KingdomRegulated

Reference pricing

JapanYes
United KingdomNo

HTA required

JapanYes
United KingdomYes

HTA body

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