§ 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	🇳🇿New Zealand	🇺🇸United States	🇪🇺European Union
Authority & dossier
Regulatory authority	Medsafe	FDA	EMA
English submissions	Yes	Yes	Yes
CTD accepted	Yes	Yes	Yes
eCTD accepted	Yes	Yes	Yes
Reliance pathway	Available	None	Available
Reference agencies	FDA, EMA, MHRA, TGA +2	—	—
Lead pathway (timeline & fees) — New Medicine Application — Full Evaluation (Section 23) · New Drug Application — 505(b)(1) · Centralised Procedure
Pathway name	New Medicine Application — Full Evaluation (Section 23)	New Drug Application — 505(b)(1)	Centralised Procedure
Approval timeline	200–520 days	304–365 days	210–277 days
Application fee	NZD 132,000	USD 4,310,002	EUR 358,800
Annual renewal	NZD 1,300	USD 416,734	EUR 122,500
Local representative	Required	Not required	Required
Local manufacturing	Not required	Not required	Not required
GMP inspection	Required	Required	Required
MAH & local presence
Local entity required	Yes	No	Yes
Local responsible person	Yes	Yes	Yes
RP role	Sponsors must designate a New Zealand contact for pharmacovigilance and adverse event reporting to CARM (Centre for Adverse Reactions Monitoring, University of Otago) under Medsafe's PV requirements.	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	3 designations	6 designations	6 designations
Examples	Priority Review, Provisional Consent (Section 23(1)(b)), Abbreviated Evaluation Procedure	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	Variations handled as Changed Medicine Notifications (CMNs) under Section 24 of the Medicines Act 1981. CMNs are categorised by impact (self-assessable Section 24(5)(a) notifications versus Section 24(5)(b) referrals requiring Medsafe assessment).	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	Consents granted under the Medicines Act 1981 do not have a fixed expiry; sponsors pay annual product fees and maintain the consent through ongoing compliance with conditions, CMNs and pharmacovigilance obligations.	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	MA holders must report adverse reactions to CARM under Medsafe's PV requirements (15-day for serious unlisted), submit PSURs aligned to ICH E2C(R2), and maintain RMPs for new active substances and biologics. Medsafe publishes Prescriber Update and safety communications.	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	45–90 days	30–30 days	60–106 days
GCP standard	ICH E6(R2/R3) GCP	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	Pharmac — Pharmacology and Therapeutics Advisory Committee (PTAC) and specialist subcommittees	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

New ZealandMedsafe
United StatesFDA
European UnionEMA

English submissions

New ZealandYes
United StatesYes
European UnionYes

CTD accepted

New ZealandYes
United StatesYes
European UnionYes

eCTD accepted

New ZealandYes
United StatesYes
European UnionYes

Reliance pathway

New ZealandAvailable
United StatesNone
European UnionAvailable

Reference agencies

New ZealandFDA, EMA, MHRA, TGA +2
United States—
European Union—

Lead pathway (timeline & fees) — New Medicine Application — Full Evaluation (Section 23) · New Drug Application — 505(b)(1) · Centralised Procedure

Pathway name

New ZealandNew Medicine Application — Full Evaluation (Section 23)
United StatesNew Drug Application — 505(b)(1)
European UnionCentralised Procedure

Approval timeline

New Zealand200–520 days
United States304–365 days
European Union210–277 days

Application fee

New ZealandNZD 132,000
United StatesUSD 4,310,002
European UnionEUR 358,800

Annual renewal

New ZealandNZD 1,300
United StatesUSD 416,734
European UnionEUR 122,500

Local representative

New ZealandRequired
United StatesNot required
European UnionRequired

Local manufacturing

New ZealandNot required
United StatesNot required
European UnionNot required

GMP inspection

New ZealandRequired
United StatesRequired
European UnionRequired

MAH & local presence

Local entity required

New ZealandYes
United StatesNo
European UnionYes

Local responsible person

New ZealandYes
United StatesYes
European UnionYes

RP role

New ZealandSponsors must designate a New Zealand contact for pharmacovigilance and adverse event reporting to CARM (Centre for Adverse Reactions Monitoring, University of Otago) under Medsafe's PV requirements.
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

New Zealand3 designations
United States6 designations
European Union6 designations

Examples

New ZealandPriority Review, Provisional Consent (Section 23(1)(b)), Abbreviated Evaluation Procedure
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

New ZealandVariations handled as Changed Medicine Notifications (CMNs) under Section 24 of the Medicines Act 1981. CMNs are categorised by impact (self-assessable Section 24(5)(a) notifications versus Section 24(5)(b) referrals requiring Medsafe assessment).
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

New ZealandConsents granted under the Medicines Act 1981 do not have a fixed expiry; sponsors pay annual product fees and maintain the consent through ongoing compliance with conditions, CMNs and pharmacovigilance obligations.
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

New ZealandMA holders must report adverse reactions to CARM under Medsafe's PV requirements (15-day for serious unlisted), submit PSURs aligned to ICH E2C(R2), and maintain RMPs for new active substances and biologics. Medsafe publishes Prescriber Update and safety communications.
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

New ZealandAvailable
United StatesAvailable
European UnionAvailable

Compassionate Use

New ZealandAvailable
United StatesAvailable
European UnionAvailable

Emergency Import

New ZealandAvailable
United StatesAvailable
European UnionAvailable

Parallel Import

New ZealandPermitted
United StatesNot permitted
European UnionPermitted

Clinical trials

CTA approval

New ZealandRequired
United StatesRequired
European UnionRequired

Ethics approval

New ZealandYes
United StatesYes
European UnionYes

CTA timeline

New Zealand45–90 days
United States30–30 days
European Union60–106 days

GCP standard

New ZealandICH E6(R2/R3) GCP
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

New ZealandRegulated
United StatesFree pricing
European UnionRegulated

Reference pricing

New ZealandYes
United StatesNo
European UnionYes

HTA required

New ZealandYes
United StatesNo
European UnionYes

HTA body

New ZealandPharmac — Pharmacology and Therapeutics Advisory Committee (PTAC) and specialist subcommittees
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.)