§ 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	🇪🇺European Union	🇯🇵Japan
Authority & dossier
Regulatory authority	EMA	PMDA
English submissions	Yes	No
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	None
Reference agencies	—	—
Lead pathway (timeline & fees) — Centralised Procedure · J-NDA (New Drug Application)
Pathway name	Centralised Procedure	J-NDA (New Drug Application)
Approval timeline	210–277 days	270–365 days
Application fee	EUR 358,800	JPY 38,950,800
Annual renewal	EUR 122,500	JPY 0
Local representative	Required	Required
Local manufacturing	Not required	Not required
GMP inspection	Required	Required
MAH & local presence
Local entity required	Yes	Yes
Local responsible person	Yes	Yes
RP role	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).	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	6 designations	4 designations
Examples	Accelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3	Priority Review, Orphan Drug Designation, Conditional Early Approval (Article 14-2-3) +1
Post-approval lifecycle
Variations framework	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.	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 — 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.	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	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.	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	60–106 days	30–30 days
GCP standard	ICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025	J-GCP (Ministerial Ordinance No. 28, 1997, as amended) — fully ICH E6 aligned
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	Yes	Yes
HTA required	Yes	Yes
HTA body	EU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)	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

European UnionEMA
JapanPMDA

English submissions

European UnionYes
JapanNo

CTD accepted

European UnionYes
JapanYes

eCTD accepted

European UnionYes
JapanYes

Reliance pathway

European UnionAvailable
JapanNone

Reference agencies

European Union—
Japan—

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

Pathway name

European UnionCentralised Procedure
JapanJ-NDA (New Drug Application)

Approval timeline

European Union210–277 days
Japan270–365 days

Application fee

European UnionEUR 358,800
JapanJPY 38,950,800

Annual renewal

European UnionEUR 122,500
JapanJPY 0

Local representative

European UnionRequired
JapanRequired

Local manufacturing

European UnionNot required
JapanNot required

GMP inspection

European UnionRequired
JapanRequired

MAH & local presence

Local entity required

European UnionYes
JapanYes

Local responsible person

European UnionYes
JapanYes

RP role

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).
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

European Union6 designations
Japan4 designations

Examples

European UnionAccelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3
JapanPriority Review, Orphan Drug Designation, Conditional Early Approval (Article 14-2-3) +1

Post-approval lifecycle

Variations framework

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.
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

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.
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

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.
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

European UnionAvailable
JapanAvailable

Compassionate Use

European UnionAvailable
JapanAvailable

Emergency Import

European UnionAvailable
JapanAvailable

Parallel Import

European UnionPermitted
JapanNot permitted

Clinical trials

CTA approval

European UnionRequired
JapanRequired

Ethics approval

European UnionYes
JapanYes

CTA timeline

European Union60–106 days
Japan30–30 days

GCP standard

European UnionICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
JapanJ-GCP (Ministerial Ordinance No. 28, 1997, as amended) — fully ICH E6 aligned

Pricing & reimbursement

Price regulation

European UnionRegulated
JapanRegulated

Reference pricing

European UnionYes
JapanYes

HTA required

European UnionYes
JapanYes

HTA body

European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)
JapanChuikyo (Central Social Insurance Medical Council) and C2H (Center for Outcomes Research and Economic Evaluation for Health, NIPH)