§ 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 Fees verified 12 September 2026	🇺🇸United States Fees verified 12 September 2026
Authority & dossier
Fee confirmation	Fees verified 12 September 2026	Fees verified 12 September 2026
Regulatory authority	PMDA	FDA
English submissions	No	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	None	None
Reference agencies	Not stated	Not stated
Lead pathway (timeline & fees), J-NDA (New Drug Application) · New Drug Application, 505(b)(1)
Pathway name	J-NDA (New Drug Application)	New Drug Application, 505(b)(1)
Approval timeline	270-365 days	304-365 days
Headline fee and pathway	JPY 46,901,700, J-NDA (New Drug Application)conditional on other	USD 4,682,003, New Drug Application, 505(b)(1)conditional on other
Recurring charges	No recurring fee	USD 442,213 a year, per product
Local representative	Required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Required
MAH & local presence
Local entity required	Yes	No
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.	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.
Accelerated pathways
Designations available	4 designations	6 designations
Examples	Priority Review, Orphan Drug Designation, Conditional Early Approval (Article 14-2-3) +1	Priority Review, Breakthrough Therapy Designation, Accelerated Approval, Subpart H/E +3
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).	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.
Renewal cycle	Re-examination period of 4 to 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.	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.
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.	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.
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	J-GCP (Ministerial Ordinance No. 28, 1997, as amended), fully ICH E6 aligned	ICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56
Pricing & reimbursement
Price regulation	Regulated	Free pricing
Reference pricing	Yes	No
HTA required	Yes	No
HTA body	Chuikyo (Central Social Insurance Medical Council) and C2H (Center for Outcomes Research and Economic Evaluation for Health, NIPH)	ICER (Institute for Clinical and Economic Review), independent, non-binding

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

Authority & dossier

Fee confirmation

JapanFees verified 12 September 2026
United StatesFees verified 12 September 2026

Regulatory authority

JapanPMDA
United StatesFDA

English submissions

JapanNo
United StatesYes

CTD accepted

JapanYes
United StatesYes

eCTD accepted

JapanYes
United StatesYes

Reliance pathway

JapanNone
United StatesNone

Reference agencies

JapanNot stated
United StatesNot stated

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

Pathway name

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

Approval timeline

Japan270-365 days
United States304-365 days

Headline fee and pathway

JapanJPY 46,901,700, J-NDA (New Drug Application)conditional on other
United StatesUSD 4,682,003, New Drug Application, 505(b)(1)conditional on other

Recurring charges

JapanNo recurring fee
United StatesUSD 442,213 a year, per product

Local representative

JapanRequired
United StatesNot required

Local manufacturing

JapanNot required
United StatesNot required

GMP inspection

JapanRequired
United StatesRequired

MAH & local presence

Local entity required

JapanYes
United StatesNo

Local responsible person

JapanYes
United StatesYes

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 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.

Accelerated pathways

Designations available

Japan4 designations
United States6 designations

Examples

JapanPriority Review, Orphan Drug Designation, Conditional Early Approval (Article 14-2-3) +1
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval, Subpart H/E +3

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 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.

Renewal cycle

JapanRe-examination period of 4 to 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 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.

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 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.

Unlicensed access

Named Patient Supply

JapanAvailable
United StatesAvailable

Compassionate Use

JapanAvailable
United StatesAvailable

Emergency Import

JapanAvailable
United StatesAvailable

Parallel Import

JapanNot permitted
United StatesNot permitted

Clinical trials

CTA approval

JapanRequired
United StatesRequired

Ethics approval

JapanYes
United StatesYes

CTA timeline

Japan30-30 days
United States30-30 days

GCP standard

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

Pricing & reimbursement

Price regulation

JapanRegulated
United StatesFree pricing

Reference pricing

JapanYes
United StatesNo

HTA required

JapanYes
United StatesNo

HTA body

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