§ 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	🇰🇷South Korea	🇺🇸United States
Authority & dossier
Regulatory authority	MFDS	FDA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	None	None
Reference agencies	FDA, EMA, MHRA, PMDA +3	—
Lead pathway (timeline & fees) — New Drug Application — Standard Review · New Drug Application — 505(b)(1)
Pathway name	New Drug Application — Standard Review	New Drug Application — 505(b)(1)
Approval timeline	365–480 days	304–365 days
Application fee	KRW 8,500,000	USD 4,310,002
Annual renewal	KRW 1,500,000	USD 416,734
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	Qualified Person for Safety Management (안전관리책임자): Korea-resident pharmacist responsible for pharmacovigilance and post-marketing safety obligations. A separate Quality Manager is required for manufacturing/import licences.	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	5 designations	6 designations
Examples	Global Innovative Products on Fast Track (GIFT), Priority Review, Conditional Approval +2	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
Post-approval lifecycle
Variations framework	MFDS classifies post-approval changes as Major, Moderate, and Minor variations, broadly aligned with EU classification. Annual report categories also exist for the smallest changes.	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	Marketing authorisations require renewal every 5 years. Renewal application must be submitted 6 months before expiry. Re-examination period (재심사기간) of 4–6 years applies to new drugs requiring active safety monitoring with full re-evaluation.	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	Korea Adverse Event Reporting System (KAERS) administered by the Korea Institute of Drug Safety and Risk Management (KIDS). PSURs aligned with ICH E2C(R2). MAH must appoint a Qualified Person for Safety Management and maintain a pharmacovigilance system.	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	30–60 days	30–30 days
GCP standard	Korean GCP (KGCP, ICH E6(R3) 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	Health Insurance Review and Assessment Service (HIRA) — Pharmaceutical Benefits Coverage Assessment Committee	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

Regulatory authority

South KoreaMFDS
United StatesFDA

English submissions

South KoreaYes
United StatesYes

CTD accepted

South KoreaYes
United StatesYes

eCTD accepted

South KoreaYes
United StatesYes

Reliance pathway

South KoreaNone
United StatesNone

Reference agencies

South KoreaFDA, EMA, MHRA, PMDA +3
United States—

Lead pathway (timeline & fees) — New Drug Application — Standard Review · New Drug Application — 505(b)(1)

Pathway name

South KoreaNew Drug Application — Standard Review
United StatesNew Drug Application — 505(b)(1)

Approval timeline

South Korea365–480 days
United States304–365 days

Application fee

South KoreaKRW 8,500,000
United StatesUSD 4,310,002

Annual renewal

South KoreaKRW 1,500,000
United StatesUSD 416,734

Local representative

South KoreaRequired
United StatesNot required

Local manufacturing

South KoreaNot required
United StatesNot required

GMP inspection

South KoreaRequired
United StatesRequired

MAH & local presence

Local entity required

South KoreaYes
United StatesNo

Local responsible person

South KoreaYes
United StatesYes

RP role

South KoreaQualified Person for Safety Management (안전관리책임자): Korea-resident pharmacist responsible for pharmacovigilance and post-marketing safety obligations. A separate Quality Manager is required for manufacturing/import licences.
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

South Korea5 designations
United States6 designations

Examples

South KoreaGlobal Innovative Products on Fast Track (GIFT), Priority Review, Conditional Approval +2
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3

Post-approval lifecycle

Variations framework

South KoreaMFDS classifies post-approval changes as Major, Moderate, and Minor variations, broadly aligned with EU classification. Annual report categories also exist for the smallest changes.
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

South KoreaMarketing authorisations require renewal every 5 years. Renewal application must be submitted 6 months before expiry. Re-examination period (재심사기간) of 4–6 years applies to new drugs requiring active safety monitoring with full re-evaluation.
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

South KoreaKorea Adverse Event Reporting System (KAERS) administered by the Korea Institute of Drug Safety and Risk Management (KIDS). PSURs aligned with ICH E2C(R2). MAH must appoint a Qualified Person for Safety Management and maintain a pharmacovigilance system.
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

South KoreaAvailable
United StatesAvailable

Compassionate Use

South KoreaAvailable
United StatesAvailable

Emergency Import

South KoreaAvailable
United StatesAvailable

Parallel Import

South KoreaNot permitted
United StatesNot permitted

Clinical trials

CTA approval

South KoreaRequired
United StatesRequired

Ethics approval

South KoreaYes
United StatesYes

CTA timeline

South Korea30–60 days
United States30–30 days

GCP standard

South KoreaKorean GCP (KGCP, ICH E6(R3) aligned)
United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56

Pricing & reimbursement

Price regulation

South KoreaRegulated
United StatesFree pricing

Reference pricing

South KoreaYes
United StatesNo

HTA required

South KoreaYes
United StatesNo

HTA body

South KoreaHealth Insurance Review and Assessment Service (HIRA) — Pharmaceutical Benefits Coverage Assessment Committee
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding