§ 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	🇯🇵Japan
Authority & dossier
Regulatory authority	FDA	PMDA
English submissions	Yes	No
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	None	None
Reference agencies	—	—
Lead pathway (timeline & fees) — New Drug Application — 505(b)(1) · J-NDA (New Drug Application)
Pathway name	New Drug Application — 505(b)(1)	J-NDA (New Drug Application)
Approval timeline	304–365 days	270–365 days
Application fee	USD 4,310,002	JPY 38,950,800
Annual renewal	USD 416,734	JPY 0
Local representative	Not required	Required
Local manufacturing	Not required	Not required
GMP inspection	Required	Required
MAH & local presence
Local entity required	No	Yes
Local responsible person	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.	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	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3	Priority Review, Orphan Drug Designation, Conditional Early Approval (Article 14-2-3) +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.	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	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.	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	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.	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	Not permitted	Not permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	30–30 days	30–30 days
GCP standard	ICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56	J-GCP (Ministerial Ordinance No. 28, 1997, as amended) — fully ICH E6 aligned
Pricing & reimbursement
Price regulation	Free pricing	Regulated
Reference pricing	No	Yes
HTA required	No	Yes
HTA body	ICER (Institute for Clinical and Economic Review) — independent, non-binding	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 StatesFDA
JapanPMDA

English submissions

United StatesYes
JapanNo

CTD accepted

United StatesYes
JapanYes

eCTD accepted

United StatesYes
JapanYes

Reliance pathway

United StatesNone
JapanNone

Reference agencies

United States—
Japan—

Lead pathway (timeline & fees) — New Drug Application — 505(b)(1) · J-NDA (New Drug Application)

Pathway name

United StatesNew Drug Application — 505(b)(1)
JapanJ-NDA (New Drug Application)

Approval timeline

United States304–365 days
Japan270–365 days

Application fee

United StatesUSD 4,310,002
JapanJPY 38,950,800

Annual renewal

United StatesUSD 416,734
JapanJPY 0

Local representative

United StatesNot required
JapanRequired

Local manufacturing

United StatesNot required
JapanNot required

GMP inspection

United StatesRequired
JapanRequired

MAH & local presence

Local entity required

United StatesNo
JapanYes

Local responsible person

United StatesYes
JapanYes

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.
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 States6 designations
Japan4 designations

Examples

United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
JapanPriority Review, Orphan Drug Designation, Conditional Early Approval (Article 14-2-3) +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.
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 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.
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 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.
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 StatesAvailable
JapanAvailable

Compassionate Use

United StatesAvailable
JapanAvailable

Emergency Import

United StatesAvailable
JapanAvailable

Parallel Import

United StatesNot permitted
JapanNot permitted

Clinical trials

CTA approval

United StatesRequired
JapanRequired

Ethics approval

United StatesYes
JapanYes

CTA timeline

United States30–30 days
Japan30–30 days

GCP standard

United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56
JapanJ-GCP (Ministerial Ordinance No. 28, 1997, as amended) — fully ICH E6 aligned

Pricing & reimbursement

Price regulation

United StatesFree pricing
JapanRegulated

Reference pricing

United StatesNo
JapanYes

HTA required

United StatesNo
JapanYes

HTA body

United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding
JapanChuikyo (Central Social Insurance Medical Council) and C2H (Center for Outcomes Research and Economic Evaluation for Health, NIPH)