§ 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
Authority & dossier
Regulatory authority	Medsafe	FDA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	None
Reference agencies	FDA, EMA, MHRA, TGA +2	—
Lead pathway (timeline & fees) — New Medicine Application — Full Evaluation (Section 23) · New Drug Application — 505(b)(1)
Pathway name	New Medicine Application — Full Evaluation (Section 23)	New Drug Application — 505(b)(1)
Approval timeline	200–520 days	304–365 days
Application fee	NZD 132,000	USD 4,310,002
Annual renewal	NZD 1,300	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	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.
Accelerated pathways
Designations available	3 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
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.
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.
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.
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	45–90 days	30–30 days
GCP standard	ICH E6(R2/R3) GCP	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	Pharmac — Pharmacology and Therapeutics Advisory Committee (PTAC) and specialist subcommittees	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

New ZealandMedsafe
United StatesFDA

English submissions

New ZealandYes
United StatesYes

CTD accepted

New ZealandYes
United StatesYes

eCTD accepted

New ZealandYes
United StatesYes

Reliance pathway

New ZealandAvailable
United StatesNone

Reference agencies

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

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

Pathway name

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

Approval timeline

New Zealand200–520 days
United States304–365 days

Application fee

New ZealandNZD 132,000
United StatesUSD 4,310,002

Annual renewal

New ZealandNZD 1,300
United StatesUSD 416,734

Local representative

New ZealandRequired
United StatesNot required

Local manufacturing

New ZealandNot required
United StatesNot required

GMP inspection

New ZealandRequired
United StatesRequired

MAH & local presence

Local entity required

New ZealandYes
United StatesNo

Local responsible person

New ZealandYes
United StatesYes

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.

Accelerated pathways

Designations available

New Zealand3 designations
United States6 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

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.

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.

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.

Unlicensed access

Named Patient Supply

New ZealandAvailable
United StatesAvailable

Compassionate Use

New ZealandAvailable
United StatesAvailable

Emergency Import

New ZealandAvailable
United StatesAvailable

Parallel Import

New ZealandPermitted
United StatesNot permitted

Clinical trials

CTA approval

New ZealandRequired
United StatesRequired

Ethics approval

New ZealandYes
United StatesYes

CTA timeline

New Zealand45–90 days
United States30–30 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

Pricing & reimbursement

Price regulation

New ZealandRegulated
United StatesFree pricing

Reference pricing

New ZealandYes
United StatesNo

HTA required

New ZealandYes
United StatesNo

HTA body

New ZealandPharmac — Pharmacology and Therapeutics Advisory Committee (PTAC) and specialist subcommittees
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding