§ 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	🇪🇺European Union
Authority & dossier
Regulatory authority	DKMA	FDA	EMA
English submissions	Yes	Yes	Yes
CTD accepted	Yes	Yes	Yes
eCTD accepted	Yes	Yes	Yes
Reliance pathway	Available	None	Available
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) · Centralised Procedure
Pathway name	EU Centralised Procedure	New Drug Application — 505(b)(1)	Centralised Procedure
Approval timeline	210–300 days	304–365 days	210–277 days
Application fee	EUR 350,000	USD 4,310,002	EUR 358,800
Annual renewal	EUR 130,000	USD 416,734	EUR 122,500
Local representative	Not required	Not required	Required
Local manufacturing	Not required	Not required	Not required
GMP inspection	Required	Required	Required
MAH & local presence
Local entity required	No	No	Yes
Local responsible person	Yes	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.	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).
Accelerated pathways
Designations available	4 designations	6 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	Accelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +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.	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.
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.	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.
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.	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.
Unlicensed access
Named Patient Supply	Available	Available	Available
Compassionate Use	Available	Available	Available
Emergency Import	Available	Available	Available
Parallel Import	Permitted	Not permitted	Permitted
Clinical trials
CTA approval	Required	Required	Required
Ethics approval	Yes	Yes	Yes
CTA timeline	60–106 days	30–30 days	60–106 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	ICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation	Regulated	Free pricing	Regulated
Reference pricing	Yes	No	Yes
HTA required	Yes	No	Yes
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	EU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)

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

Authority & dossier

Regulatory authority

DenmarkDKMA
United StatesFDA
European UnionEMA

English submissions

DenmarkYes
United StatesYes
European UnionYes

CTD accepted

DenmarkYes
United StatesYes
European UnionYes

eCTD accepted

DenmarkYes
United StatesYes
European UnionYes

Reliance pathway

DenmarkAvailable
United StatesNone
European UnionAvailable

Reference agencies

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

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

Pathway name

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

Approval timeline

Denmark210–300 days
United States304–365 days
European Union210–277 days

Application fee

DenmarkEUR 350,000
United StatesUSD 4,310,002
European UnionEUR 358,800

Annual renewal

DenmarkEUR 130,000
United StatesUSD 416,734
European UnionEUR 122,500

Local representative

DenmarkNot required
United StatesNot required
European UnionRequired

Local manufacturing

DenmarkNot required
United StatesNot required
European UnionNot required

GMP inspection

DenmarkRequired
United StatesRequired
European UnionRequired

MAH & local presence

Local entity required

DenmarkNo
United StatesNo
European UnionYes

Local responsible person

DenmarkYes
United StatesYes
European UnionYes

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.
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).

Accelerated pathways

Designations available

Denmark4 designations
United States6 designations
European Union6 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
European UnionAccelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +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.
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.

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.
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.

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.
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.

Unlicensed access

Named Patient Supply

DenmarkAvailable
United StatesAvailable
European UnionAvailable

Compassionate Use

DenmarkAvailable
United StatesAvailable
European UnionAvailable

Emergency Import

DenmarkAvailable
United StatesAvailable
European UnionAvailable

Parallel Import

DenmarkPermitted
United StatesNot permitted
European UnionPermitted

Clinical trials

CTA approval

DenmarkRequired
United StatesRequired
European UnionRequired

Ethics approval

DenmarkYes
United StatesYes
European UnionYes

CTA timeline

Denmark60–106 days
United States30–30 days
European Union60–106 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
European UnionICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025

Pricing & reimbursement

Price regulation

DenmarkRegulated
United StatesFree pricing
European UnionRegulated

Reference pricing

DenmarkYes
United StatesNo
European UnionYes

HTA required

DenmarkYes
United StatesNo
European UnionYes

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
European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)