§ 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	🇩🇰Denmark	🇺🇸United States
Authority & dossier
Regulatory authority	DKMA	FDA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	None
Reference agencies	EMA (Centralised Procedure — directly valid), EU/EEA Member States (DCP / MRP), EU CMDh	—
Lead pathway (timeline & fees) — EU Centralised Procedure · New Drug Application — 505(b)(1)
Pathway name	EU Centralised Procedure	New Drug Application — 505(b)(1)
Approval timeline	210–300 days	304–365 days
Application fee	EUR 350,000	USD 4,310,002
Annual renewal	EUR 130,000	USD 416,734
Local representative	Not required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Required
MAH & local presence
Local entity required	No	No
Local responsible person	Yes	Yes
RP role	QPPV established in the EEA (any EEA member) per EU GVP Module I; QPPV is the contact for DKMA pharmacovigilance. Danish-language pharmacovigilance literature monitoring required for products marketed in Denmark. A Pharmacovigilance System Master File (PSMF) location must be declared.	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	Accelerated Assessment (EMA CP), Conditional Marketing Authorisation (CMA), PRIME (Priority Medicines) +1	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
Post-approval lifecycle
Variations framework	EU variations framework (Commission Regulation 1234/2008 as amended) — Type IA / IAIN (do-and-tell), Type IB (tell-wait-do), Type II (prior approval), Extensions and Article 61(3) notifications. DKMA processes variations for nationally / DCP / MRP authorised products; EMA processes variations for centrally-authorised products.	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	Standard renewal at 5 years post first authorisation; subsequent unlimited validity unless DKMA / EMA decides on safety grounds to require further renewal. CMAs renewed annually until conversion to full MA.	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	EU pharmacovigilance framework (Directive 2010/84/EU and Regulation 1235/2010) implemented via Danish Medicines Act and DKMA executive orders. EudraVigilance reporting mandatory; PSURs per EURD list submitted to EMA PSUSA. Danish ADR reports collected by DKMA via the national e-reporting portal (for healthcare professionals and consumers, plus the Meldknappen quick-reporting button). DKMA holds a PRAC seat. Strong epidemiological surveillance via Danish national health registers (Civil Registration System CPR-linked; Danish National Patient Register; Danish National Prescription Registry).	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	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) GCP; EU Clinical Trials Regulation 536/2014 (EU CTR); Danish Medicines Act and Committee Act on Health Research Ethics (Komitéloven)	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	Medicinrådet (the Danish Medicines Council) for hospital medicines and treatment guidelines; the Reimbursement Committee (Medicintilskudsnævnet), which advises DKMA, for outpatient general reimbursement decisions.	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

DenmarkDKMA
United StatesFDA

English submissions

DenmarkYes
United StatesYes

CTD accepted

DenmarkYes
United StatesYes

eCTD accepted

DenmarkYes
United StatesYes

Reliance pathway

DenmarkAvailable
United StatesNone

Reference agencies

DenmarkEMA (Centralised Procedure — directly valid), EU/EEA Member States (DCP / MRP), EU CMDh
United States—

Lead pathway (timeline & fees) — EU Centralised Procedure · New Drug Application — 505(b)(1)

Pathway name

DenmarkEU Centralised Procedure
United StatesNew Drug Application — 505(b)(1)

Approval timeline

Denmark210–300 days
United States304–365 days

Application fee

DenmarkEUR 350,000
United StatesUSD 4,310,002

Annual renewal

DenmarkEUR 130,000
United StatesUSD 416,734

Local representative

DenmarkNot required
United StatesNot required

Local manufacturing

DenmarkNot required
United StatesNot required

GMP inspection

DenmarkRequired
United StatesRequired

MAH & local presence

Local entity required

DenmarkNo
United StatesNo

Local responsible person

DenmarkYes
United StatesYes

RP role

DenmarkQPPV established in the EEA (any EEA member) per EU GVP Module I; QPPV is the contact for DKMA pharmacovigilance. Danish-language pharmacovigilance literature monitoring required for products marketed in Denmark. A Pharmacovigilance System Master File (PSMF) location must be declared.
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

Denmark4 designations
United States6 designations

Examples

DenmarkAccelerated Assessment (EMA CP), Conditional Marketing Authorisation (CMA), PRIME (Priority Medicines) +1
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3

Post-approval lifecycle

Variations framework

DenmarkEU variations framework (Commission Regulation 1234/2008 as amended) — Type IA / IAIN (do-and-tell), Type IB (tell-wait-do), Type II (prior approval), Extensions and Article 61(3) notifications. DKMA processes variations for nationally / DCP / MRP authorised products; EMA processes variations for centrally-authorised products.
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

DenmarkStandard renewal at 5 years post first authorisation; subsequent unlimited validity unless DKMA / EMA decides on safety grounds to require further renewal. CMAs renewed annually until conversion to full MA.
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

DenmarkEU pharmacovigilance framework (Directive 2010/84/EU and Regulation 1235/2010) implemented via Danish Medicines Act and DKMA executive orders. EudraVigilance reporting mandatory; PSURs per EURD list submitted to EMA PSUSA. Danish ADR reports collected by DKMA via the national e-reporting portal (for healthcare professionals and consumers, plus the Meldknappen quick-reporting button). DKMA holds a PRAC seat. Strong epidemiological surveillance via Danish national health registers (Civil Registration System CPR-linked; Danish National Patient Register; Danish National Prescription Registry).
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

DenmarkAvailable
United StatesAvailable

Compassionate Use

DenmarkAvailable
United StatesAvailable

Emergency Import

DenmarkAvailable
United StatesAvailable

Parallel Import

DenmarkPermitted
United StatesNot permitted

Clinical trials

CTA approval

DenmarkRequired
United StatesRequired

Ethics approval

DenmarkYes
United StatesYes

CTA timeline

Denmark60–106 days
United States30–30 days

GCP standard

DenmarkICH E6(R3) GCP; EU Clinical Trials Regulation 536/2014 (EU CTR); Danish Medicines Act and Committee Act on Health Research Ethics (Komitéloven)
United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56

Pricing & reimbursement

Price regulation

DenmarkRegulated
United StatesFree pricing

Reference pricing

DenmarkYes
United StatesNo

HTA required

DenmarkYes
United StatesNo

HTA body

DenmarkMedicinrådet (the Danish Medicines Council) for hospital medicines and treatment guidelines; the Reimbursement Committee (Medicintilskudsnævnet), which advises DKMA, for outpatient general reimbursement decisions.
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding